In the last installment we looked at the first part of the Strategic Roadmap – Addiction which specifically focused on opioids and nicotine. However, the next part of the FDA Strategic Policy Roadmap is less specific and instead is focused on the very broad topics of Improving Health Care Access Issues and Public Health. That means within this category ends up being a bit of a hodge-podge because just about any enhancements to regulatory oversight would arguably be likely accomplish these rather broad goals.
- Improving Product Development and Strengthening FDA’s Gold Standard
- This is sort of what the 21st Century Cures Act was all about – reducing the regulatory burden without compromising safety and that phrase has become a mantra in the many missives from the Commissioner’s office and in FDA as it implements the Act. It also is a carry-over of a campaign theme for this Administration. That said, the lowering of the regulatory hurdles has been less draconian than otherwise might have been and FDA has been taking a comprehensive, but measured approach;
- Last year, FDA approved a record number of new molecular entities with 46 medicines getting the thumbs up;
- FDA unveiled a plan to eliminate the Orphan Drug designation backlog and announced its success by the Fall of 2017;
- Look for how this pans out given the budget proposal made by the Administration which shifts a greater role for user fee generated support for FDA than before and, if that is the way the budget does develop, how that impacts approval times and funding for safety and sentinel activity and programs;
- So far this year, FDA has only approved 4 new molecular entities, which would sound like it is off compared to 2017, but in fact by the end of February of last year, the agency had only approved 5 so the agency has lots of time if the pipeline supplies the applications;
- Promoting Generic Drug Competition
- Generics are the one area where FDA can impact pricing through its actions – the more generics approved for a treatment, the further down the price is supposed to go and generics account for a huge percentage of the prescriptions written in the U.S. and XX of these approvals involved “firsts” into the market;
- In June of 2017 FDA published a list of off-patent drugs that did not have generic competition and implemented a new policy to expedite review of generic applications in categories where there are fewer than three generics approved in a category and in January of this year, issued a draft guidance on Good ANDA submission practices to add clarity to the approval process for generics;
- The agency also announced that 2017 was a record year for approval of generics;
- Look for the possibility of FDA to address the perceived “gaming” of the system to delay generic entries in the market – in a blog posting last year, Commissioner Gottlieb alluded to efforts to work with the Federal Trade Commission in identifying and publicizing activities deemed to be anti-competitive and look for guidance documents in the first quarter on aspects of gaming, including potential abuses of the citizen petition process, restricting access to testing samples of branded drugs and abuses of the single, shared system REMS negotiation process;
- Look also for a concentration on complex generics.
In the next installment – Empowering Consumers.
