Of course, it is entirely a subjective matter to pick out the most interesting stories of the year. When it comes to an agency that oversees the regulation of one-quarter of the U.S. economy spanning everything from medicines to cosmetics to (some) food to packaging. In other words, it all kind of depends on where you have your hand on the elephant. Nevertheless, I’m taking a shot here at naming what I think were the biggest developments out of FDA this year. I did not focus on therapeutic breakthroughs, though there were some real advances in Hepatitis C, oncology and prosthetics, but more on stories that give us insights into the agency and policy.
- FDA Changes Stance on Blood Donations from Gay Men – More on this front in a future posting, but FDA announced in December that it was changing the policy on blood donation from men who have sex with men. It is an interesting story even if you are not in the blood industry or gay for many reasons, among them it provides a window into just how slow and laborious the process is when it comes to change at the agency. Prior policy had been that all blood donations from men who have had sex with men at any time since 1977 were entirely deferred. In December, FDA announced that it will be taking steps to recommend a change that will allow blood donation from gay men under the condition that it has been at least one year since any sexual contact (with other men). While a policy likely not to please anyone, it nevertheless is policy change from the long-standing prior policy. FDA will issue a draft guidance that will include opportunity for public comment. In the meantime, the agency has set up a Q&A page.
- FDA Approves Host of Orphan Drugs – Quickly – This year, FDA approved a great number of new drugs, which in and of itself is newsworthy. However, among the drugs approved, there were a large number that were approved for rare or orphan conditions and were approved quickly through FDA’s mechanisms for facilitating approvals. One need only breeze through the long list of approvals that are in the FDA press releases for 2014 and you will see many notices for treatments for rare conditions. These include the approval of Blincyto to treat a rare from of leukemia, a new treatment – Obizur – for a rare form of hemophilia, two new treatments for idiopathic pulmonary fibrosis, and a new treatment for Castleman’s disease, to name only a few – and a new indication was cleared for Jakafi to treat patients with a chronic type of bone marrow disease. It was the year of attending rare disorders.
- FDA Cold Storage Harbored Pathogens – At the beginning of July it was reported by CDC that the FDA cold storage area located on the NIH campus apparently held some old vials of various biological agents that included packaged vials of dengue, influenza, Q fever and rickettsia as well as smallpox. At the time, the thinking was that this collection was assembled between 1946 and 1964. FDA stated in an update in mid-July that the overlooked samples was clearly unacceptable and that the agency would be in the process of reviewing its policies and procedures and put into place a corrective action plan.
- FDA Finally Has Something to Say on Social Media – Finally, I think the biggest FDA story of the year. Health care is one of the primary uses for the Internet and the ascendancy of social media has not only provided powerful new platforms for communication, but has fueled a change in the way journalism is practices, including healthcare journalism. (Check out my piece on “Wall-Free Journalism“). After initially believing that existing rules on promotional speech by pharmaceutical companies covered social media in 2009, by year end, the agency changed its mind and held a public meeting to explore the unique questions posed by the rapid uptake in use of social media platforms, even as many companies began developing a fleet of social media assets. The agency posed five questions at that 2009 meeting and while many expected a single guidance to answer them by the end of 2010, in fact it was not until this year that FDA answered at least some (though not all) of the topics discussed by issuing some guidances. While in 2011 the agency mentioned social media in the context of a guidance “Responding to Unsolicited Requests About Off-Label Information” leading many to mistakenly consider this THE guidance on social media, and in 2013 produced some guidance on mobile medical apps, it was not until 2014 that there was some more expansive direction from the agency in the form of draft guidances affecting social media. In January, FDA published “Fulfilling Regulatory Requirements for Post-marketing Submissions” and in June published two more – one on “Platforms with Character Space Limitations” and one on “Correcting Independent Third Party Misinformation About Prescription Drugs and Medical Devices“. (You can find links to all of these on the Eye on FDA Tab on Social Media. Unfortunately, in sum, as I said at the time in the Wall Street Journal Pharmalot blog – after the long wait, the result may be not much change.
Let’s get 2015 started. Please accept my wishes for a Happy New Year to everyone. May it bring good things and thanks again for being a reader of Eye on FDA in this, what will be the 9th year!