Blog Post

By: William Rankin

Influenza impacts millions of people across the world each year. According to the World Health Organization, there are 3-5 million cases of influenza with 290,000-650,000 attributable deaths each year. What makes influenza different from most viruses is the fact that it rapidly changes in shape and form due to genetic mutations. As a result, the medical community is faced with continually having to modify influenza vaccines to combat different strains of the virus each year. The predominant influenza vaccine currently on the market is produced by propagating a weakened virus in chicken eggs. Although this production method is widely approved and considered safe, it presents several challenges. First, the egg-based method is highly dependent on a supply of vaccine-quality eggs. In the case of an unforeseen event, such as avian flu, the supply of these eggs can be at risk of serious shortage. Second, the egg-based production method is very time consuming due to various processing steps. And third, because of the inherent egg usage, the current prevailing vaccine cannot be administered to people who have egg or feather allergies.
Two FDA-approved non-egg-based flu vaccines, developed by Protein Sciences (now Sanofi) and Seqirus, show strong potential as alternative vaccines that are quicker to produce, more risk-averse, and available to a wider patient base. The Sanofi vaccine is produced by a method that involves propagating the influenza virus in an insect cell line known as SF9, while the Seqirus design is propagated in canine cells. Studies have shown that the effectiveness of these cell-based vaccines can be 10-11% higher than egg-based vaccines in preventing hospital encounters, inpatient stays, and clinic visits. While production time for the cell-based vaccines have been proven to be as much as 50% shorter than the prevailing egg-based method. If past flu pandemics have taught us anything, it is the importance of speed and efficacy when it comes to flu vaccine production. In addition to the decrease in production time and increase in effectiveness of the vaccines, the reliability in production far exceeds that of the egg-based design. The cell-based vaccines are not reliant on production materials subject to variation, such as eggs or antibiotics, allowing the cell-based vaccines to be produced on a consistent basis for all users.
The disadvantages of the cell-based vaccine compared with their egg-based counterpart are essentially twofold: regulatory hurdles and cost of goods. However, the regulatory hurdles have become less of a barrier in recent years as the Sequris vaccine, Flucelvax Quadrivalent, was approved by the FDA in 2016, and Sanofi quickly followed with FDA approval on Flublok. These approvals show that the high initial regulatory burden of showing the vaccine’s safety has already been met, allowing further development to meet specified regulations as well. Although cell-based production costs remain higher than the egg-based vaccine, under the cell-based production system there is far greater potential for multi-vaccine application of the production system due to the sterile disposable nature of the process. Currently, the egg-based production design only supports significant commercial manufacture of influenza and yellow fever vaccines, whereas the cell-based design could allow for many different vaccines to be produced using the same system. In turn, this diversified use of the production system could increase the yield of total vaccines that the cell-based design can produce, offsetting the expensive nature of the system.
Accounting for all these factors, it may be time to consider cell-based vaccines as the new norm in the influenza vaccine community. If the benefits are there, and the obstacles are beginning to wane, it may soon be that convention is the only thing keeping egg-based production methods prevalent.

Sources:
Influenza (Seasonal), WORLD HEALTH ORG. (Nov. 6, 2018), https://www.who.int/en/news-room/fact-sheets/detail/influenza-(seasonal).

Michael Johnsen, Protein Sciences gains extensive patent protection for Flublok vaccine, DRUG STORE NEWS (June 4, 2015), https://drugstorenews.com/pharmacy/protein-sciences-gains-extensive-patent-protection-flublok.

Bernd Kalbfuss, et al., Puri?cation of Cell Culture-Derived Human In?uenza A Virus by Size-Exclusion and Anion-Exchange Chromatography, BIOTECHNOLOGY AND BIOENGINEERING (Aug. 25, 2006).

Michael L. Perdue, et al., The future of cell culture-based influenza vaccine production, EXPERT REV. OF VACCINES (Aug. 2011).

Lisa Schnirring, Study: Cell-based flu vaccine just a bit better than egg-based, U. OF MINN. CTR. FOR INFECTIOUS DISEASE RES. AND POL’Y (Dec. 18, 2018), http://www.cidrap.umn.edu/news-perspective/2018/12/study-cell-based-flu-vaccine-just-bit-better-egg-based.

Seqirus receives FDA approval for FLUCELVAX QUADRIVALENT™ (Influenza Vaccine) for people four years of age and older, CISION PR NEWSWIRE (May 23, 2016 8:50 AM), https://www.prnewswire.com/news-releases/seqirus-receives-fda-approval-for-flucelvax-quadrivalent-influenza-vaccine-for-people-four-years-of-age-and-older-300273578.html.

Michael R. Page, FDA Approves Flublok Quadrivalent Flu Vaccine, CONTAGIONLIVE (Oct. 13, 2016), https://www.contagionlive.com/news/fda-approves-flublok-quadrivalent-flu-vaccine.

Cell-Based Flu Vaccines, CTRS. FOR DISEASE CONTROL AND PREVENTION (Oct. 11, 2019), https://www.cdc.gov/flu/prevent/cell-based.htm.

By: Meredith Wallen

What is the harm in taking photographs of yourself that have been taken by someone else and then posting those photographs to your own personal Instagram page or other social media platform? Well if you are Katy Perry, Gigi Hadid, Jennifer Lopez or a number of other celebrities, it could cost you $150,000 per photograph.  Katy Perry dressed as Hillary Clinton for Halloween in 2016, and later posted a photograph taken by the paparazzi to her Instagram page. Perry failed to pay the paparazzi agency to license the photograph and failed to give credit to the agency.

This is an ongoing issue in the entertainment industry, with multiple celebrities facing copyright infringement lawsuits for using the photographs that have been taken of them by the paparazzi and posting the photographs on their personal social media pages without paying or giving credit to the copyright holders.

Copyright law grants the copyright owner the exclusive right to reproduce, distribute, or publish the protected work.  The official page for the United States Copyright Office states that the “mission of the Copyright Office is to promote creativity by administering and sustaining an effective national copyright system.”  The primary purpose behind the copyright system is to promote creativity in society by giving those individuals that choose to create art the security of knowing that what they create will be protected and not able to be reproduced or republished without proper compensation to the artist or the artist’s prior consent.

The United States Copyright Office’s functions include, but are not limited to the administering of copyright law and creating and maintaining a public record through registration of claims and recordation of documents.  Photographs and photographic negatives were added to protected works under copyright law on March 3, 1865.  It is much harder to regulate the reproduction or publication of photographs now than it was years ago because of the accessibility factor.  Social media platforms such as Instagram and Twitter make it much easier to take a photo off of one page and repost it to your own personal page, without ever having to acknowledge or give credit to who holds the copyright for the original photograph.

Paparazzi agencies are continuing to bring more suits against celebrities, and the celebrities are typically settling with the rights holders, which means that most of the suits never make it past preliminary motions. Model Gigi Hadid has dealt with her fair share of copyright infringement lawsuits when it comes to reposting photographs to her social media. Recently the photo agency Xclusive-Lee filed a copyright infringement suit against Hadid in the Eastern District of New York.  Xclusive-Lee’s complaint highlighted that Hadid has had a prior suit brought against her for copyright infringement with the hope that this evidence could show that Hadid was aware she was unable to use a photo of herself taken by a member of the paparazzi community without gaining prior consent or compensating the photographer. Hadid has previously settled when sued over copyright infringement; however, with this suit Hadid and her attorney raised the Fair-Use Doctrine under Section 107 of the Copyright Act in their motion to dismiss.

Section 107 of the Copyright Act states that “the fair use of a copyrighted work,” and here that would be the plaintiff’s photograph of the celebrity, “including such use by reproduction in copies or phonorecords or by any other means specified by that section, for purposes such as criticism, comment, news, reporting, teaching, scholarship, or research is not an infringement of copyright.” One factor to be considered in determining whether the use made of a work in any particular case is a fair use is the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit education purposes. The photograph of Hadid is clearly more of a commercial nature rather than nonprofit or educational purpose. However, Hadid is claiming that she had made no effort to commercially exploit the photograph, but rather the photographer’s intent in taking the photograph “was to commercially exploit Hadid’s popularity.”  This is a risky argument for a celebrity to make considering they are typically exploiting themselves when they are choosing to interact with the public and are themselves boosting their popularity through the use of these photographs on their social media platforms, which makes these photographs of them more desired and of “newsworthy” material to the public.

The other factors in play when considering the Fair-Use Doctrine are the nature of the copyrighted work, the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and the effect of the use upon the potential market for or value of the copyrighted work. The affected use in regard to celebrities republishing these photographs of themselves without paying or even giving credit to the photographers, could substantially affect the potential market for or value of the copyrighted work.  These photographers are being compensated for the capturing of these celebrities’ image by selling the photographs to different social media or news outlets, so if the photographers are not being compensated for or to the extent that they should be, these photographers could in turn lose the incentive to take the photographs which would substantially affect the market for these types of photographs.

Hadid’s argument focused on the first element of § 107, “purpose and character of the use.” Courts tend to look to what extent the work is transformative, which is the extent the new work alters the original work with new expression, meaning or message when analyzing the purpose and character.  Hadid argued that her posting the photograph of herself on Instagram is transformative because the nature of her use was social and not commercial like the intention of the paparazzi.  The reposting of the same photograph, even if a filter or different caption is added to the photograph, is most likely not transformative regardless of the change in purpose of commercial to social.  Hadid also made the argument that her posing for the photographer created an implied license between the photographer and herself.  If this policy was adopted, photographers would certainly suffer a direct economic loss because the need of purchasing photographs would be essentially obliterated if all it took was an implied license that could be gained by what is considered “posing for the camera.”

An argument can be made that celebrities are not directly gaining from an economic sense when posting these photographs of themselves on their personal pages; however, their profiles are being boosted and can indirectly lead to an economic boost with each new post.  One example of this is a lawsuit against Ariana Grande for posting two photographs taken by a New York-based paparazzo who captured Grande carrying a bag that read “Sweetener.”  The photographer alleged that his photographs of Grande were used by Grande to promote her then soon-to-be-released album of the same name.  On the other side of that same argument is would be that these are photographs of the individual being sued and these celebrities are without a doubt being exploited for commercial purposes.

Celebrities can attempt to argue the defense right of publicity which grants an individual the right to control and profit from commercial use of their name or likeness, but it does not grant the right to inhibit the First Amendment right. New York law takes into account the “newsworthiness” and “public interest” factors when considering the right of publicity defense.  Courts will typically rule that when photos are taken in a public place and are of a “newsworthy” subject (i.e. a famous popstar), the photographer has copyright ownership.  Regardless of the outcome for each celebrity, whether it be by a private settlement or a motion to dismiss including a fair-use defense, this is an ongoing issue that will most likely end with a bright line rule of law needing to be established in an effort to minimize the amount of copyright infringement suits coming forward.

Cites:

A Brief Introduction and History, United States Copyright Office (Nov. 4, 2019), https://www.copyright.gov/circs/circ1a.html.

Amy Ralph Mudge, Randal M. Shaheen, Alan L. Friel and Linda A. Goldstein, Gigi Hadid “Obliterates” Copyrights With Fair-Use Bazooka, Lexology (June 28, 2019), https://www.lexology.com/library/detail.aspx?g=e162b58c-9e96-4857-8505-5b58042af129.

Copyright Act of 1976 § 101, 17 U.S.C. § 106 (2019).

Copyright Act of 1976 § 101, 17 U.S.C. § 107 (2019).

Legal Entertainment, Ariana Grande Hit With Lawsuit For Posting Paparazzi Photo Of Herself, Forbes (May 14, 2019), https://www.forbes.com/sites/legalentertainment/2019/05/14/ariana-grande-hit-with-lawsuit-for-posting-paparazzi-photo-of-herself/#3ddcd6ff4f39.

Ken Shepherd, Khloe Kardashian sued by paparazzi photo agency for $175k for sharing copyrighted photo on Instagram, Washington Times (April 27, 2017), https://www.washingtontimes.com/news/2017/apr/27/khloe-kardashian-sued-photographer-violating-copyr/.

Maria Puente, Jennifer Lopez sued by paparazzi agency for copyright infringement, USA Today  (Oct 7, 2019), https://www.usatoday.com/story/entertainment/celebrities/2019/10/07/jennifer-lopez-sued-paparazzi-copyright-infringement/3900908002/. 

Quinn D’Isa, Gigi Hadid, Paparazzi, and The Intersection of Copyright Laws and Fair Use on Social Media, (2019), http://www.fordhamiplj.org/2019/09/25/gigi-hadid-paparazzi-and-the-intersection-of-copyright-laws-and-fair-use-on-social-media/ (last visited Nov 4, 2019).

By:  Jessiya Joseph

Facebook is the world’s largest social network that also owns photo app Instagram, messaging service WhatsApp, and virtual reality company Oculus. In June 2019, the House antitrust committee said it was launching an investigation into Facebook. The Federal Trade Commission and the Department of Justice are both reportedly investigating Facebook over antitrust concerns. 47 Attorney Generals are now investigating Facebook’s potential anticompetitive conduct to determine whether Facebook’s actions subdued competition and put users at risk.

Facebook proposed a new venture of creating its very own digital currency, Libra. Libra has been an important subject in U.S. congressional hearings. Lawmakers worry that Libra has the potential to disrupt the monetary system. If Libra becomes the currency for Facebook’s 2.4 billion or so users, it has the potential to become a globally significant currency.

Libra is incorporated in Switzerland. It would be what’s called in crypto markets, as stable coin. It will be a pegged currency that maintains one-to-one value with the U.S. dollar. This peg will be maintained by a company called Libra Association. It is a newly created currency governing body that includes a total of 21 members that will together drive the project.

For the first time, not a government, but a group of private companies together could hold the power that can upset global markets. Libra Association will function to maintain a reserve. For every dollar’s worth of Libra that is created, one dollar is going to be put into the reserve. Theoretically this reserve has the potential to sustain billions or even trillions of dollars, worth of currencies and short-term securities. Although, the companies are committed to work with the authorities to ensure a safe, transparent and consumer friendly implementation, it remains a concern for many governments. Needless to say, this proposal has gotten a lot of backlash from global regulators. France’s finance minister goes on to say that it is an assault on national sovereignty. Moreover, officials of other countries, including China, Germany, and Italy have experienced similar concerns.

Facebook has been criticized for the way of handling its user data before, and Libra would create a traceable record of all its users transactions. Lawmakers are skeptical about Facebook’s ability to combine user’s identity, online habits, and their spending patterns, should this proposal come into force. Facebook Executive David Marcus has presented himself once before, in the Summer Congressional Hearings of 2019, reassuring the privacy of the user identity and the spending data. Currently, Libra’s viability is still under regulatory scrutiny and is unlikely to come into force anytime soon.

The House that was already concerned about Facebook’s likely anti-competitive nature, heard Mark Zuckerberg’s prepared remarks at the Financial Services Committee Hearing, regarding its proposal to create its very own digital currency. While the hearing was supposed to be about Facebook’s push to create Libra, about half of the topics were related to its controversial political ads policy and Facebook’s record on diversity. Zuckerberg told lawmakers repeatedly that Facebook would not support launching the cryptocurrency unless it received approval from all US regulators. Indeed, Facebook is the brains behind this idea, but it is just one of the 21 partners in the Libra Association. Facebook is willing to leave the Libra Association, if the approval does not come through.

But the lawmakers continue to be skeptical about how promising Libra could be. Even Zuckerberg at one point conceded that it is a “risky project”, which did not help his situation. Other members of Congress remain skeptical solely because this project is in affiliation with Facebook, questioning his very credibility, honesty, and motive behind Libra. Moreover, the members of Congress seemed to also have an issue with Libra’s Association’s place of incorporation being Switzerland and not the U.S. They would probably be little more assured if it incorporated in the U.S. One of the Congressional members went on to say, “Today Facebook is more like a country, than like a company.”

Zuckerberg’s testimony may still not have been enough to address the many questions lawmakers have about Libra. Near the end of the hearing, which lasted more than six hours, the committee’s ranking member Rep. Patrick Henry said he is not sure the committee members had “learned anything new here.”

Carrie Mihalcik, Facebook now faces 47 attorneys general in antitrust probe, msn: news, https://www.msn.com/en-us/news/technology/facebook-now-faces-47-attorneys-general-in-antitrust-probe/ar-AAJaIld (Oct. 22, 2019, 12:45 PM).

Julie Verhage and Kurt Wagner, Facebook CEO Says Libra Won’t Launch Until U.S. Approves, msn: news, https://www.msn.com/en-us/news/technology/facebook-ceo-says-libra-wont-launch-until-us-approves/ar-AAJaZkS (Oct. 22, 2019).

Paul Vigna, The Global Backlash Against Facebook’s Digital Currency Project, WSJ Video, https://www.wsj.com/video/the-global-backlash-against-facebooks-digital-currency-project/2C62D390-CFC9-4865-96D7-E7AD2B467826.html?mod=article_inline (Oct. 22, 2019, 7:02 AM).

Kurt Wagner, Facebook’s Mark Zuckerberg Heads Back to Washington for Questioning, Bloomberg: Politics, https://www.bloomberg.com/news/articles/2019-10-22/facebook-s-zuckerberg-heads-back-to-washington-for-questioning (Oct. 22, 2019, 10:42 AM EDT).

Theodore Schleifer, Congress couldn’t agree on what exactly was wrong with Mark Zuckerberg. But they all wanted a piece of him, Vox, https://www.vox.com/recode/2019/10/23/20928859/libra-hearing-congress-mark-zuckerberg (Oct. 23, 2019, 4:40 PM EDT).

Claire Duffy and Brian Fung, Mark Zuckerberg grilled by Congress over Libra and political ads policy, CNN BUSINESS, https://www.cnn.com/2019/10/23/tech/mark-zuckerberg-facebook-libra-hearing/index.html (Oct. 23, 2019, 4:26 PM ET).

By: Sofia Feliciano

What are deepfakes? Many people don’t even know what deepfakes are, much less their threat on society today. A deepfake is a fake or doctored video or audio recording that looks or sounds just like a real video or audio recording. A deepfake is usually not detectable as false by the average viewer or listener. Deepfakes are made using generative adversarial networks, or GANs. Two machine learning models are tested against one another. The first uses a data set provided (such as real video footage) to create a forged video and the second attempts to detect the forgery. The first model continues to create the fake video until the second model can no longer detect the forgery.

Can deepfakes be detected? Yes, usually, but the problem here is time. It usually takes between 24-48 hours to detect the use of deepfake technology. Also, it takes time for other publications of the same event to come out, at which point comparisons to the deepfake can be made to determine its falsity. But one of the dangers of deepfakes is that anyone can download deepfake software and begin to create deepfakes. There is even an app that people can download directly onto their phones – FakeApp.

Deepfakes are likely to be the next big problem for the 2020 elections. Recently, deepfake technology has been used to create videos that look like they show politicians saying or doing things they never said or did. A popular video that has gained much traction in the news is the deepfake video of House Speaker Nancy Pelosi. The President tweeted out doctored footage of Pelosi where it seemed as if she was stuttering through her speech. This deepfake of Pelosi gained more than 2.5 million views on Facebook alone, as Facebook was unable to identify the fake Pelosi video.

Deepfakes could have disastrous implications for those running for positions in our government as well as for the upcoming 2020 election. Deepfakes are a powerful technology that people could use to disseminate misinformation to influence an election. Worse, if the public becomes aware of mass deepfakes being spread over the course of a campaign, voters may become cynical about the ability to discern truth from falsehood. This could lead to apathy and low voter turnout. Additionally, the increase of deepfakes being spread in the media could mean that politicians could try to deny things that really did happen, using the public’s doubts to their own gain.

Some politicians have expressed their concerns with the increasing use of deepfakes. Florida Senator Marco Rubio called deepfakes the “modern equivalent of nuclear weapons.” The fear Rubio is encapsulating is that deepfakes could be used in nefarious means, such as exploitation to start military conflicts by falsely portraying hostilities that never existed. Imagine a widespread circulation of a deepfake of the President saying we have started a war with Russia, China, or any other superpower in the world. The effects could be catastrophic, especially when the ability to identify the falsity of the video would be limited until a day or two after the release of such a video.

Two states have already begun to take action against deepfakes. California has passed a bill, AB 730, that prohibits the distribution of doctored audio or video of a candidate, unless it is clearly marked as a fake. However, this would only be applicable if that deepfake media is distributed within 60 days of an election. The law hinges on whether the distribution of the deepfake could lead a normal person to have a fundamentally different impression of the candidate. However, critics of this law have argued that it is overbroad, vague, and subjective, as “fundamentally different impression” was undefined. Critics also have noted the difficulties this law could have in respect to satirists and parodies. Texas has also passed a similar deepfake law, in which it is now a misdemeanor to create and distribute deepfakes within 30 days of an election, with the intent to harm a candidate or somehow influence an election.

But what else can be done? As of right now, it is still not a federal crime in the United States to create fake videos. However, two federal level bills have recently been introduced with the aim of controlling the use of deepfakes – (1) the Malicious Deep Fake Prohibition Act, introduced in December 2018, and (2) the DEEPFAKES Accountability Act, introduced in June 2019.

The Malicious Deep Fake Prohibition Act was introduced by Senator Ben Sasse. Its purpose is to amend title 18 of the U.S.C to prohibit “certain fraudulent audiovisual records.” This bill defines a deepfake as “an audiovisual record created or altered in a manner that record would falsely appear to a reasonable observer to be an authentic record or the actual speech or conduct of an individual.” If passed, it would make it unlawful for someone to (1) create a deepfake with the intent to distribute it as to facilitate either criminal or tortious conduct, or (2) distribute a deepfake when they have actual knowledge that it is a deepfake and the intent that it would facilitate criminal or tortious conduct.

The DEEPFAKES Accountability Act was introduced by House Representative Yvette Clarke. This bill is a more extensive restriction of the regulation to deepfake audio and visual recordings, requiring deepfakes to display a digital watermark as well as audiovisual disclosures of the alterations to the video. Penalties for failures to disclose or alterations of disclosures include fines up to $150,000 or imprisonment for not more than 5 years, or both.

As technology in our society continues to advance at a rapid pace, these two bills are a start to the beginning of regulating deepfake technology nationwide. It is likely that more states will adopt deepfake laws in preparation for the upcoming 2020 election. With more state support, the chances of national regulation against malicious deepfake use, especially in connection with democratic elections, will only increase. Until then, the public needs to keep a sharp eye out for any more fake news.

Citations:

1. Levi Sumagaysay, California Has A New Deepfakes Law In Time For 2020 Election, THE MERCURY NEWS (Oct. 4, 2019, 3:14 PM), https://www.mercurynews.com/2019/10/04/california-has-a-new-deepfakes-law-in-time-for-2020-election/.

2. Grace Shao, Fake Videos Could Be The Next Big Problem In The 2020 Elections, CNBC TECH (Oct. 15, 2019, 9:40 AM), https://www.cnbc.com/2019/10/15/deepfakes-could-be-problem-for-the-2020-election.html.

3. Philip Ewing, What You Need To Know About Fake Video, Audio, And The 2020 Election, NPR (Sept. 2, 2019, 7:00 AM), https://www.npr.org/2019/09/02/754415386/what-you-need-to-know-about-fake-video-audio-and-the-2020-election.

4. Will Fischer, California’s Governor Signed New Deepfake Laws For Politics And Porn, But Experts Say They Threaten Free Speech, BUSINESS INSIDER (Oct. 10, 2019, 12:51 PM), https://www.businessinsider.com/california-deepfake-laws-politics-porn-free-speech-privacy-experts-2019-10.

5. J.M. Porup, How And Why Deepfake videos work – And What Is At Risk, CSO ONLINE (Apr. 10, 2019, 3:00 AM), https://www.csoonline.com/article/3293002/deepfake-videos-how-and-why-they-work.html.

6. Doctored Nancy Pelosi Video Highlights Threat of “Deepfake” Tech, CBS NEWS (May 25, 2019, 12:39 PM), https://www.cbsnews.com/news/doctored-nancy-pelosi-video-highlights-threat-of-deepfake-tech-2019-05-25/.

7. DEEPFAKES Accountability Act of 2019, H.R. 3230, 116th Cong. (1st Sess. 2019).

8. Malicious Deep Fake Prohibition Act of 2018, S. 3805, 115th Cong. (2d. Sess. 2018).

9. Mike Wendling, The (almost) complete history of ‘fake news’, BBC News, (Jan. 22, 2018),  https://www.bbc.com/news/blogs-trending-42724320.

By: Elizabeth K. Harraka

Descovy is a new HIV prevention drug, created by Gilead pharmaceuticals, that the FDA recently approved for use by cisgender men and transgender women. This is the second drug of its kind available in the United States, the first being Truvada which is also sold by Gilead. These two drugs are categorized as PrEP, pre-exposure prophylaxis, which is an HIV prevention plan that requires a daily dosage of the drug to prevent contracting the disease before exposure. The ability to present options for patients to choose from is a success for continuing efforts to reduce HIV rates. However, the road to Descovy’s approval was not without criticism and controversy.

The FDA, an administrative agency, published a notice for the pending approval of the drug in the Federal Register. They scheduled a comment hearing on August 7, 2019. The notice and comment period are a requirement for informal rulemaking in administrative agencies. Gilead is a pharmaceutical company that must abide by the rules and policies set by the FDA. The notice and comment period are necessary so that the public may voice any concerns or issues regarding the proposed rule. There is no limit to the number of comments allowed; agencies are expected to listen and incorporate comments that would improve the rule to better serve the public’s health and safety. The hearing granted advocates and other various health organizations a venue to voice requests and raise concerns regarding Descovy and its impending FDA approval.

One main concern raised at the hearing was that Gilead wanted to infer the result by extrapolating data from other testing so that Descovy could be approved for use by cisgender women. Gilead proposed this idea because they never conducted their test trials to include women. People spoke out against this because there is no definite understanding of the drug effects in women long-term. The committee held a vote as to whether they should take the Descovy trial testing data and other PrEP data to extend the approval to use by women. The committee voted 10-8 against extending Descovy approval to women’s usage before conducting trial testing. Those who voted against its use were worried about setting a precedent that the FDA did not always have to conduct thorough and proper drug testing to get approval. Those who voted in favor considered that equity balance between men and women and the number of PrEP drugs available to each group.

Gilead failed to test Descovy for women. Instead, they ran trials on men and transgender men only. Gilead simply should have conducted testing on women as well. The company stated that the percentage of female patients is only 10%. This is a low percentage but that does not mean that these women should not have access to or be completely excluded from potential health treatments. Gilead also said that they tested only men so that the drug could be approved sooner.

The second issue raised at the hearing was that Gilead overstated the success and safety of Descovy over Truvada. Many people thought that Gilead exaggerated to ensure their profits and maintain customers once generic cheaper versions of the medication become available next year. Advocates and medical professionals questioned the degree to which Gilead touts the benefits of Descovy by pushing the new drug onto patients who currently take Truvada. They worry Gilead is over-hyping the safety of Descovy and the “minimal impact” on kidney and renal toxicity that the company says is much better than Truvada. Gilead seems to insinuate that Descovy is the safest prescription option. Many people think that the pharmaceutical company is doing this as a business practice so that patients continue paying for one of their products. Next year a rival pharmaceutical company will put out a generic version of Truvada on the market that will likely cost less than the current price. Truvada currently runs about $20,000 a year and Descovy will cost the same amount.

At the public meeting, one advocate group demanded a cost reduction of Descovy to $1 per pill (currently, each pill costs about $60). The exact price demand was dropped, but constant criticism remains regarding the costs of PrEP. Many people have questioned the motives behind Gilead’s actions and their ethical duty to provide medicine to individuals regardless of gender or income. While most insurance and healthcare providers cover the cost of PrEP, advocates worry that the company may create a stigma that the expensive drug is better and more effective than the cheaper drug.

The approval process for Descovy by the FDA highlights the informal rulemaking process. Agencies conduct rulemaking this way so that the public can be involved and so that the rules passed by agencies best serve the public by protecting our health and safety. Advocate groups and foundations, doctors and individual citizens were able to critique and voice potential solutions to issues regarding Descovy’s trial testing and costs. Without the public forum to hear multiple opinions, the FDA committee may have gone ahead and voted in favor of Gilead’s request to approve Descovy for women without ever conducting proper testing. Thankfully, the committee voted against this decision and understood that it would be too big of a risk to the public. The committee listened to the public’s request and the FDA issued a requirement that Gilead conduct a post-market study that will include women. Hopefully the company is receptive to the comments regarding the price of the pill and reduces the cost.

Sources:

Andrew F. Popper et al.,Administrative Law: A Contemporary Approach (3d ed. 2016).

Apoorva Mandavilli, F.D.A. Approves New H.I.V.-Prevention Drug, but Not for Cis-Gend Womener, N.Y. Times,(Oct. 8, 2019), https://www.nytimes.com/2019/10/04/health/fda-descovy-truvada-hiv.html.

Harron Walker, Congrats to Big Pharma on Finding a New Way to Profit Off of HIV Prevention, Vice(Oct. 4, 2019), https://www.vice.com/en_us/article/wjw4qn/descovy-prep-hiv-prevention.

Kyle Blankenship, Gilead called on to ‘significantly cut’ HIV med Descovy’s price in PrEP,FiercePharma(Oct. 7, 2019), https://www.fiercepharma.com/pharma/a-1-pill-gilead-called-to-significantly-cut-price-hiv-aids-med-descovy.

Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 84 Fed. Reg. 121, 29521 (June 24, 2019).

Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment for a Public Docket; Request for Comments, 83 Fed. Reg. 181, 47177, 181, 47178 (Sept. 18, 2018).

FDA Panel Issues Split-Decision for Gilead’s HIV Prevention Drug, Drug Indus. Daily, Aug. 8, 2019.

Gilead’s Proposed PrEP Drug Sparks Data Extrapolation, Cost Concerns, Inside Health Reform, Aug. 14, 2019.

By: Jacqueline Chilbert

Tech giants and online industry leaders have come under great scrutiny in the past few years, every move seems to be followed by political unrest. But recent changes in legislation have forced the companies to become more creative in their practices while also being more transparent.

Technology giants, like Amazon, Google and Apple have rolled out several new Artificial Intelligence technologies in the past 5 years and are constantly announcing the newest edition of each of these products, but what are we sacrificing when we feed into this phenomenon?

While privacy has been a growing concern, there are more issues behind the scenes. Recently many states have begun investigations into potential anti-competitive behaviors of these tech companies. For example, Facebook has a newly launched dating site. This site has not been proven better or of greater quality, but the fear is that the data collection Facebook uses from profiles and ads, mixed with their intense reach of over a quarter of the population, they will prevent small start-ups from launching and may even diminish the use of current dating apps solely because the Facebook name is so well known and already has widespread use.

Google has also faced scrutiny in this call for revolution. There has been a call for action and investigation by 48 states who are fearful of Google’s influence and dominance. Texas Attorney General noted the company is threating the structure of the economy “as they dominate the buyer side, the seller side, the auction side, and even the video side with YouTube.” Google provides ‘free’ services to consumers, why would they not take advantage of them. The dilemma is these seemingly free services track usage and data to help set prices and influence the supply of goods. Almost 60% of digital advertising is controlled by Google and Facebook. This forces companies who want to advertise online to abide by any terms, conditions, and prices, the two major companies set.

Democratic candidate, Elizabeth Warren, has taken a forward stance on regulating the technology giants, when she “called for breaking up Amazon.com Inc., Facebook Inc. and Alphabet Inc,” and accused the companies of undermining democracy. It is likely that technology companies will come under even more scrutiny and will find themselves at the top of the reform “list” for many candidates in the wake of the coming elections.

Taking a look at these concerns beyond the United States, Europe has also taken great strides to combat the giant technology companies. Europe is known for their strict and expressed rights to privacy which guarantee much more protection to an individual than the implied privacy rights of the United States. The Court of Justice of the European Union, the equivalent of the U.S. Supreme Court, has just ruled that Facebook must take down slanderous and defamatory content from their site and remove all access to that information around the world.

However, Google still brought home a win for tech companies in another case where the court ruled that Europe’s rights cannot be extended beyond the European countries recognizing that individual rights in other countries may not be as expansive.

This court opinion emphasizes the need for regulation of the internet industry and with technology companies alike but also shows the difficulty of regulating companies who have a world-wide reach. When countries around the world have different standards for internet usage it is difficult to find neutral, all-inclusive regulations that will make a difference in practice.

The growing concerns for the dangers of anticompetitive behavior and privacy are not only coming from government perspectives but, Brad Smith, current Microsoft President has recently come out to warn of the dangers that lack of regulation on the tech industry can have on democracy. “If public leaders don’t… the Internet giants will cannibalize the very fabric of this country.”

There is a fine line to be found in these concerns. Does society want the best experience and use of technology, or does it want their right to privacy and fair competition protected? Tech companies have argued that the best way to keep the products to the highest standard and available to all is through the collection of user data. But by consumers use of these products they are consenting to an infringement of privacy. The companies also argue that their wide reach allows them to combat the concerns of misuse because there are clear communication channels between the services.

As the 2020 election approaches, the concerns voiced will only become more prominent. It is evident that anti-competitive behaviors and private data collection will remain at the forefront of political and legislative conversations. It will be interesting to see where many of these investigations go and whether the companies will be able to maneuver to stay steps ahead.

Cites:

Aarti Shahani, Microsoft President: Democracy Is At Stake. Regulate Big Tech, NPR Business (Sept, 13, 2019), https://www.npr.org/2019/09/13/760478177/microsoft-president-democracy-is-at-stake-regulate-big-tech

Andy Kroll, The Future of Election Meddling Is Americans Versus Americans, RollingStone Politics (Sept. 3, 2019), https://www.rollingstone.com/politics/politics-features/trump-election-interference-deepfake-instagram-whatsapp-879531/

Bill Chappell, ‘Right to be Forgotten’ Only Applies To Websites Inside EU, European Court Says, NPR Technology (Sept. 24, 2019), https://www.npr.org/2019/09/24/763857307/right-to-be-forgotten-only-applies-inside-eu-european-court-says

Chris Isidore, Hanna Ziady, A court ordered Facebook to take down a post. The decision could affect social media around the world. CNN Business (Oct. 3, 2019), https://www.cnn.com/2019/10/03/tech/facebook-eu-court/index.html

David Shepardson, Elizabeth Culliford, UPDATE 4-Facebook’s Zuckerberg says Warren as U.S. president would be bad for tech, CNBC Wires (Oct. 1, 2019), https://www.cnbc.com/2019/10/01/reuters-america-update-4-facebooks-zuckerberg-says-warren-as-u-s-president-would-be-bad-for-tech.html

Jennifer Liberto, Avie Schneider, Is Facebook Too Big? State Attorneys General Want To Know, NPR Technology (Sept. 6, 2019), https://www.npr.org/2019/09/06/758232704/is-facebook-too-big-state-attorneys-general-want-to-know

Julian Barnes, Adam Goldman, F.B.I. Warns of Russian Interference in 2020 Race and Boosts Counterintelligence Operations, The New York Times (Apr. 26, 2019),
https://www.nytimes.com/2019/04/26/us/politics/fbi-russian-election-interference.html

Katie Collins, EU can order Facebook to remove illegal content worldwide, court rules, MSN News, (Oct. 3, 2019), https://www.msn.com/en-us/news/technology/eu-can-order-facebook-to-remove-illegal-content-worldwide-court-rules/ar-AAIdFY9

By: Viviana C. Bro

The advent of the automobile turned city streets into havoc. Records from the early 1900s reveal countless hit-and-runs, the running over of children playing on the streets, and even the stoning of reckless motorists. The increasing number of vehicles, combined with a lack of regulation and enforcement, recklessness and intoxication has created a chaotic environment.[1]By the mid-1920s, however, the government had introduced a national, uniform approach to street and highway safety. This action brought order and security, and spurred the creation of a system of national and state roads that has been connecting people across the country ever since. This system has also been crucial to our nation’s economic development.[2]Echoing the early days of the automobile, public, private and governmental entities are actively engaged in developing a cogent aerial traffic management system for Unmanned Aerial Vehicles (“UAVs”), also known as “drones.”

Congress has vested on the Federal Aviation Administration (“FAA”) the exclusive authority to regulate airspace use, including the creation of plans and policy for the use of navigable airspace, assuring its efficient use and the safety of aircrafts. To that effect, the FAA “prescribe[s] air traffic regulations on the flight of aircrafts, including regulations on safety altitudes” intended to protect people and property on the ground. It also assists with navigation and identification of aircrafts, and helps prevent collision between aircrafts and land or water

vehicles, and aircrafts and other airborne objects.[3]Since UAVs are categorized as aircraft, their

operation falls under FAA control.

In the last couple of years, UAVs have increased dramatically in number as well as complexity. Regulation, on the other hand, has lagged behind. Currently, the operation of commercial drones, drones that are used for work or business, is controlled by 14 CFR part 107. Some of the most salient elements of this piece of legislation confine drone activity to daylight hours, impose an altitude restriction of below 400 feet, limit speeds to less than 100 mph, and require visual line of sight. Additionally, drone operators have to obtain a drone pilot certification. To request exceptions to these rules, operators have to apply for waivers, which are not guaranteed, and can take months for approval.Understandably, the public and business community have clamored for meaningful and comprehensive regulation that better aligns with ever-evolving drone technology, and is able to support the economic expansion of UAVs.

Recognizing this imperative, the government has deployed several initiatives. One of them, the Unmanned Aircraft System Traffic Management (“UTM”) is charged with investigating, developing and testing UAV operations within the shared navigable airspace.[4]

The UTM is led by NASA, which has partnered with the FAA, other federal agencies, as well as academic and commercial entities, to design a system that will manage drone traffic.[5]More specific goals include the creation of a concept of operation, determining data exchange requirements, and delineating a framework to enable operation of multiple UAVs at low altitudes, beyond visual line of sight, and without the support of air traffic services.[6]The UTM research findings will also inform future regulation. Once delineated, approved and implemented, the UTM system “will be separate from but complementary to the traditional FAA air management system.”[7]

Ancillary to the UTM is the UTM Pilot Program (“UPP”). This program is designed to provide proof that the UTM system, now in research and development stage, is operational and suitable for deployment.[8]Its mandate is to advance the safe integration of UAVs into the national airspace, and provide an informed understanding of the functional specifications for UTM deployment, and assessment of the investment requirements to bring the UTM system into reality. As of January of 2019, the Department of Transportation had identified three FAA UAS test sites to participate in the UPP: Nevada Institute for Autonomous Systems, Northern Plains UAS Test Site, and Virginia Tech, Mid Atlantic Aviation Partnership. The UPP final report is expected by the end of 2019.[9]

Another recent initiative is the Unmanned Aircraft Systems (UAS) Integration Pilot Program (IPP). Operating under the auspices of the Department of Transportation, this initiative has partnered the FAA with 10 local, state and tribal governments selected from a nation-wide pool of applicants. The selectees will join forces with private sector participants to explore the further integration of drone operations. The data to be gathered from this pilot project will be

used to inform a new regulatory framework for the safe integration of drones into the nation’s airspace.[10]

These initiatives matter because they represent steps toward some meaningful systems and regulation. The public and the business sector seek clarification and guidance as concerns surge due to increased drone activity. Without guidance, there is speculation, misinformation and economic stagnation as businesses are unwilling to develop and invest in technologies that may become unfeasible once legislation is enacted.

Other countries seem to share this sentiment. A research paper that analyzed current legal frameworks for drone operation across the world reveals various levels of drone regulation, with an emphasis on avoiding harm to other aerial vehicles, as well as people and property on the ground. The study also claims that the current state of regulation inhibits research and development as well as innovation because legislation straggle behind drone technology, which negatively impacts scientific projects.[11]

Unquestionably, implementing a UAV traffic management system is a monumental challenge. Such a system must overcome enormous logistical and practical considerations prior to becoming operational. Issues such as privacy concerns, safety of air space, remote-tracking of drones, and financing of operations are overwhelming, and tend to lead to execution paralysis. Under these circumstances, it is encouraging to see drone initiatives that engender collaboration among the government, the public and the private industry. These partnerships can only move us closer to a UAV traffic management system, and development of relevant regulations.

In the early part of the last century, the automobile surged like an unstoppable wave, and forced the government, and community at large to act in unison with admirable results. Once again, the nation grapples with a formidable technology that has the potential to reshape commerce and travel. As in the past, we must embrace the challenge and seize the opportunity to forge a lasting traffic management system and infrastructure capable of nourishing drone technology expansion, and unlocking its full economic potential.

[1]Bill Loomis, 1900-1930: The years of driving dangerously, The Detroit News (April 26, 2015), https://www.detroitnews.com/story/news/local/michigan-history/2015/04/26/auto-traffic-history-detroit/26312107/.

[2]Contributions and Crossroads Timeline, U.S. Department of Transportation Federal Highway Administration, https://www.fhwa.dot.gov/candc/timeline.cfm.

[3]  State and Local Regulation of Unmanned Aircraft Systems (UAS) Fact Sheet, Federal Aviation Administration Office of the Chief Counsel (Dec. 17, 2015), https://www.faa.gov/uas/resources/policy_library/media/UAS_Fact_Sheet_Final.pdf.

[4]Remarks Prepared for Delivery by U.S. Secretary of Transportation Elaine Chao, Transp. Research Board Annual Meeting, D.C., U.S. Dep’t of Transportation, (Jan. 14, 2019), https://www.transportation.gov/briefing-room/transportation-research-board-annual-meeting-washington-dc.

[5]FAQs: NASA’s Drone Traffic Management Research in Reno and Corpus Christi, NASA(May 21, 2019) https://www.nasa.gov/feature/ames/faqs-nasa-s-drone-traffic-management-research-in-reno-and-corpus-christi

[6]Unmanned Aircraft System Traffic Management(UTM), Federal Aviation Administration, https://www.faa.gov/uas/research_development/traffic_management/(last updated Feb. 1, 2019).

[7]Remarks Prepared for Delivery by U.S. Secretary of Transportation Elaine Chao, Transp. Research Board Annual Meeting, D.C., U.S. Dep’t of Transp., (Jan. 14, 2019), https://www.transportation.gov/briefing-room/transportation-research-board-annual-meeting-washington-dc.

[8]Frequently Asked Questions,Federal Aviation Admin., https://www.faa.gov/uas/research_development/traffic_management/utm_pilot_program/media/UTM_Pilot_Program_Information.pdf

[9]Id.

[10]U.S. Transportation Secretary Elaine L. Chao Announces Unmanned Aircraft Systems Integration Pilot Program Selectees(Press Release), Federal Aviation Admin., (May 9, 2018), https://www.faa.gov/news/press_releases/news_story.cfm?newsId=22755.

[11]Claudia Stoker et al., Review of the Current State of UAV Regulations, MDPI,(May 9, 2017), https://www.mdpi.com/2072-4292/9/5/459/htm.

By: Ashley Robinson

What is vaping? According to the Center on Addiction, “vaping is the act of inhaling and exhaling the aerosol, often referred to as vapor, which is produced by an e-cigarette or similar device.” Vaping is different from smoking in that e-cigarettes do not produce tobacco smoke; they produce an aerosol that consists of fine particles. E-cigarettes were introduced to the mass market in the United States in 2007 and variations of these e-cigarettes have been developed including vape pens and advanced personal vaporizers (MODS).
These various vaping devices generally work in the same way, with a battery that heats up the heating component which then turns the contents of the e-liquid into an aerosol that is inhaled into the lungs and then exhaled. The e-liquid originally contained propylene glycol or vegetable glycerin-based liquid with nicotine, flavoring and other chemicals, and metals. These devices do not contain tobacco.
The device that has been the current topic in many recent news stories is the JUUL. The JUUL is a vaping device that resembles a USB computer flash drive. This device has become increasingly popular with middle and high school students due in part to the variety of flavored e-liquid as well as the easy to hide design.
The original JUUL pods, the component that contains the e-liquid, contained nicotine. Recently, it has been discovered that people are creating THC -laced liquid to be used for vaping. There is a growing black-market for vaping products that is slowly being uncovered with drug busts, such as the one this month in Wisconsin. The police entered a house in a quiet suburban subdivision where they found slim boxes of flavored vaping cartridges. Next to these full cartridges, they found about 98,000 more empty cartridges with 57 mason jars nearby with THC-laced liquid to be used for vaping. These black-market JUUL accessories are popping up all around the country and serving customers their products online, in the streets, in pop-up stores, and even individual transactions that have been arranged through social media. All generations of buyers seem to overlook an important question, where did this accessory come from. They are not concerned with the source of their accessories, but they should be.
These contaminated THC-based vape cartridges are sold out of what are called “pen factories.” These factories buy empty vape cartridges and counterfeit packaging, and then fill them up with contaminated THC-based liquid and sell them. These cartridges may not necessarily be a health risk but for the practice of “cutting the product,” which is what occurs in other illegal drug operations to increase profit margins. The public health authorities have identified some cutting agents that may be the cause of the lung illnesses that have recently occurred. Vitamin E acetate, if not heated completely, can cause breathing problems and lung inflammation. Unfortunately, some people may not even realize that they are purchasing “contaminated” cartridges. These cartridges can come prepackaged in packaging that mimics legal vaping products. In states where THC is legal, these products end up on the market and can be sold under the guise of being legal and safe.
There have been close to 500 cases of lung illness and six deaths that have been linked to vaping so far. These numbers are staggering and due to this there is a large push to ban vapes, or at least ban flavored e-liquid. Many people believe that banning the flavored e-liquid would discourage minors from using these products. In early September, the Trump administration stated that it was going to ban the sale of most flavored e-cigarettes. The Food and Drug Administration (FDA) is working to outline a plan in the next few weeks to remove these flavored e-cigarettes and nicotine pods from the market. Some states have taken it upon themselves to ban the sale of flavored e-cigarettes. Although it seems like the number of teens using these products has actually increased recently, the FDA, the CDC, and the Trump administration are moving forward with bans and programs that are aimed at helping to decrease the number of people, especially teens, using e-cigarettes.

Citations:
1. Linda Richter, What is Vaping?, CENTER ON ADDICTION (Oct. 2018), https://www.centeronaddiction.org/e-cigarettes/recreational-vaping/what-vaping.
2. Julie Bosman and Matt Richtel, Vaping Bad: Were 2 Wisconsin Brothers the Walter Whites of THC Oils?, THE NEW YORK TIMES (Sept. 17, 2019), https://www.nytimes.com/2019/09/15/health/vaping-thc-wisconsin.html.
3. Matt Richtel and Denise Grady, Cases of Vaping-Related Lung Surge, Health Officials Say, THE NEW YORK TIMES (Sept. 11, 2019), https://www.nytimes.com/2019/09/06/health/third-death-vaping-related-disease.html?action=click&module=RelatedLinks&pgtype=Article.
4. Sheila Kaplan, Trump Administration Plans to Ban Flavored E-Cigarettes, THE NEW YORK TIMES (Sept. 11, 2019) https://www.nytimes.com/2019/09/11/health/trump-vaping.html?module=inline.