By Kristen Booth
As 2016 continues to unfold, we’ve taken a moment to reflect on some of the biggest news and events that 2015 brought. From the approval of the first US biosimilar product to celebrity and social media gossip, it was definitely a year full of action. To highlight just a few, here are some of 2015’s biggest stories.
10. Celebrity & Social Media Drama with the FDA
From the selfie that resulted in an FDA warning letter to the collapse of Lamar Odom, the Kardashian family was no stranger to FDA-related news last year.
In July, Kim Kardashian posted a selfie on her Instagram and Twitter accounts in which she was holding a bottle of Diclegis to promote the product. Diclegis is an FDA-approved prescription medication indicated for Nausea and Vomiting of Pregnancy (NVP), also known as morning sickness. Not long after the photo was published, Duchesnay, the company that manufactures Diclegis, received a warning letter from the FDA. The letter instructed the company to remove the post from the Internet, saying that it presented false or misleading information and failed to communicate any risk information associated with the use of the product. The original photo was removed and on August 30th, Kim Kardashian posted the photo again with an updated caption that read:
“#CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis. A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m re-posting and sharing this important information about Diclegis. For US Residents Only. Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.
Limitation of Use: Diclegis has not been studied in women with hyperemesis gravidarum. Important Safety Information. Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS effects of Diclegis. The most common side effect of Diclegis is drowsiness. Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so. Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents. Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis. Additional safety information can be found at www.DiclegisImportantSafetyinfo.com or www.Diclegis.com. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.”
Also involving the Kardashian family, Lamar Odom, husband of Khloe, collapsed after allegedly ingesting as many as ten Reload pills. Reload, also referred to as “herbal Viagra,” is a “supplement” that is promoted and sold for sexual enhancement. Because it is technically a supplement, it is not subject to the same safety regulations and standards as prescription and over-the-counter (OTC) drugs. The FDA has published various warnings and notices regarding these types of enhancement “supplements,” informing the public about the fraudulent claims of various products being falsely marketed as “dietary supplements” or “foods.”
9. FDA Approval of “Female Viagra”
Last year Sprout Pharmaceuticals, Inc. received FDA-approval of ADDYI™ (Flibanserin 100 MG), also known as “female Viagra.” ADDYI is a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women and the first approved drug of its kind. Not only was this a win on the pharmaceutical front, but also for the lobbying campaign that previously accused the FDA of gender bias, saying that the Agency has ignored the sexual needs of women. The drug, which was a very controversial topic among the industry and society as a whole, was approved on August 18, 2015. Sprout Pharmaceuticals, the company that originally manufactured the drug and obtained approval from the Agency, was sold to Valeant Pharmaceuticals International, Inc. two days later, on August 20th.
8. FDA Advancements in the Regulation of e-Cigarettes
Spanning from the regulation of liquid nicotine to the discussion of substantial equivalence, last year involved a plethora of regulation regarding various tobacco products. A few of the biggest include (but are not limited to) the draft guidance on the use of investigational tobacco products and the regulation of liquid nicotine.
The Regulation of Liquid Nicotine
In July the FDA published an Advance Notice of a Proposed Rulemaking (ANPRM) addressing the regulation of products containing liquid nicotine. The notice concentrated on whether the Agency should “warn the public about the dangers of nicotine exposure, especially due to inadvertent nicotine exposure in infants and children, and/or require that some tobacco products be sold in child-resistant packaging.” The rulemaking process was commenced due to an increase in calls to poison control centers as well as emergency room visits involving liquid nicotine exposure and poisoning. (For additional information, view our blog post here.)
FDA Draft Guidance: “Use of Investigational Tobacco Products”
Just a few months later, in September the FDA released a draft guidance entitled, “Use of Investigational Tobacco Products.” This document “discusses the kind of information FDA intends to consider in making enforcement decisions regarding the use of investigational tobacco products until regulations are issued and become effective or FDA provides written notice of its intent to change its enforcement policy.” When finalized, the guidance will provide the most in-depth and detailed recommendations from the Agency regarding these products. (More details on the draft guidance are available in our FDA News article, here.)
These are just two of 2015’s many guidances, rules, and regulations involving tobacco products and e-cigarettes. The Weinberg Group is most experienced firm in the field of tobacco and e-cigarette regulation. For additional information about our tobacco and e-cigarette services, call us at 202.833.8077 or email us here.
7. FDA’s Technological Advancements
2015 was a big year for the FDA and technology. One of these advancements occurred in May when the FDA published a final guidance announcing the deadline for electronic submission of drug applications. According to the guidance, it is officially mandated that NDA, BLA, ANDA, and Master File eCTD submissions will be compulsory starting May 5, 2017. In addition, commercial IND eCTD submissions will be compulsory starting May 5, 2018. Furthermore, in November the Agency made another monumental advancement with the launch of its Orange Book mobile application. It will be interesting to see what 2016 has in store as the FDA continues to make forward progress with regards to the inclusion and use of technology.
6. DTC Genetic Testing
After receiving a warning letter from the FDA nearly two years earlier, the Agency authorized 23andMe to sell its direct-to-consumer (DTC) test kit, which identifies carriers of the BLM gene mutation causing Bloom Syndrome. While the company’s journey was not without struggle and hardship, after obtaining the FDA’s authorization for the Bloom Syndrome carrier test, 23andMe also proceeded to obtain FDA approval of its Personal Genome Service (PGS) in October.
Additional information on DTC genetic testing and 23andMe’s test kit available here.
5. Resignation of the FDA Commissioner
Closing out the first quarter with a big change, in February FDA Commissioner Margaret A. Hamburg, MD, announced that she would be stepping down at the end of March. Taking her place as Acting FDA Commissioner was Stephen Ostroff, MD. Dr. Ostroff began his term on April 1, 2015, and will continue to serve until a new commissioner is appointed and takes over. When will that be, you may wonder? Although we are sorry to say that we cannot give you an exact date, we can tell you that progress is being made and Dr. Robert Califf was nominated by President Obama in September.
4. FDA-Related Legislation
With an exorbitant number of bills from both the House of Representatives and the Senate, 2015 was certainly one of the top years for FDA-related legislation. From the 21st Century Cures Act to the Accelerating Innovation in Medicine Act and everything in between, it will be interesting to watch as the proposed legislation continues its journey through the government in 2016.
3. Beginning of User Fee Negotiations
As stated in the user fee acts (PDUFA, MDUFA, GDUFA, and BsUFA), every five years the laws must be reevaluated and negotiated. The current laws were last negotiated in 2012 and are due to be reevaluated and finalized in 2017. Accordingly, the Agency began the negotiation process last year. With a number of meetings, debates, and discussions completed, the negotiation process is well underway and on the path to making the 2017 deadline.
2. Turing Pharmaceuticals’ Infamous Price Increase
In August of last year, Turing Pharmaceuticals acquired Daraprim, an antiparasitic compound. The product has been on the market for nearly 62 years and is used with other medications to treat toxoplasmosis, a serious parasite infection of the body, brain, or eye. In addition, Daraprim is also used to prevent toxoplasmosis infection in people suffering from HIV.
Almost immediately following the acquisition, Martin Shkreli, the founder and former CEO of Turing Pharmaceuticals increased the price of Daraprim from $13.50 to $750 per tablet. This drastic price hike grabbed the attention of news outlets and headlines worldwide.
Since the increase, Shkreli has received continuous and widespread criticism. In addition, he resigned from his position in the company after being arrested by the FBI on charges of securities fraud in December.
1. The US Arrival of Biosimilars
Perhaps one of the largest and most monumental events of 2015 was the approval of the first biosimilar product in the United States. Though they have been commercially available in Europe and other parts of the world for quite some time, the FDA approved ZarxioTM (filgrastim-sndz) as the first US biosimilar in March.
However, along with the approval came retaliation. Zarxio (filgrastim-sndz), is a biosimilar alternative to Amgen’s anti-infection drug Neupogen and is manufactured by Sandoz, a division of Novartis. Following the FDA’s green light for Zarxio, the fight between Amgen and Sandoz began and was settled later in the year with a fight in court over Novartis’ right to sell Zarxio. Novartis won the battle, receiving acknowledgement of its right to sell the ground breaking product. On September 3, Sandoz announced the availability of Zarxio in the US.
It will be interesting to watch as more biosimilar products seek FDA approval and we are eager to see what the next approved product will be.
2015 was an eventful year for everyone in the pharmaceutical industry. We hope that you accomplished whatever you set out to achieve and that you experienced great success. As we prepare for another big year ahead, we hope 2016 turns out just as well.
Are you seeking FDA approval for your product? Do you need assistance with all regulatory and compliance facets of your product(s)? We can help. Our unique approach combines a deep scientific knowledge with regulatory expertise and has a track record of helping our clients achieve successful outcomes with FDA. To learn more about how we can help you, email us here.
Written by Kristen Booth, Marketing Associate at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please reach out to us by email.