No one knows what President Trump would do next but we can certainly wish that the new perspective would possibly resolve a few issues that have challenged pharma-FDA relations for the last few years. There have been major disagreements over the rigid interpretation of regulations by FDA. Yesterday, the US Congress passed the 21st Century Cures Act with overwhelming bipartisan support. This act which is expected to become the law before President Obama leaves office is expected to have major impact on how FDA regulates the industry. But there are many other issues that the industry would want to resolve under the new administration. Here is our pick of seven issues that we believe must be on the wish list of concerned parties.
- Off-label promotion: FDA’s enforcement of off-label promotion of regulated products has been a constant bone of contention between the industry and FDA. While FDA acknowledges that new uses of approved products are an important part of medical care, it does not like companies to overtly use such information for commercial gains, for obvious reasons. Two court rulings against FDA have strengthened the industry resolve to use all information about their products whether on- or off-label. There is provision in the 21st Century Cures Act to use “Real World Evidence” to support new uses of approved products, basically using data from patient records outside of clinical trials to seek FDA approval. This should provide a way for FDA and industry to agree on a process whereby companies can generate data supportive of label amendment using medical experience data, provided it meets quality standards similar to the ones proposed for medical devices earlier this year.
- Price control of drugs: It is highly unlikely that the new administration will take any measures to legislate drug price control, a measure strongly opposed by the industry. Enough said.
- LDT and genetic diagnostic: With thousands of LDTs in the US market and the rapidly increasing genetic diagnostics industry, most of which are claimed to be LDTs, the diagnostic industry was very wary of the revisions to the LDT regulations proposed by FDA in 2014. Those revisions are probably not going anywhere. Perhaps sensing that it was likely at the losing end of the argument to revise LDT regulation, FDA announced last week that it is suspending the LDT guidance documents and waiting for directions from the new administration. The industry would essentially want to close this discussion in its favor.
- HCT/Ps: The regulation of HCT/Ps is another highly contentious area of regulation. The last public hearing and draft guidance on the topic got more than 7000 comments mostly negative of FDA. The 21st Century Cures Act contains 4 new laws for HCT/Ps as regenerative medicine. These laws are expected to reduce the burden of proof for market approval of regenerative medicine products. However, the new laws do not address stem cells from bone marrow, fat tissue, and other sources used by hundreds of doctors in the US for self-treatment of patients. The industry would probably want FDA to step back and use the same enforcement discretion it has followed so far, primarily enforcing quality and safety but not efficacy requirements. This is as good as any time to get this wish.
- Biologics exclusivity: Just like price control, the 12-year exclusivity for new biologics is likely safe under this administration. The industry may want to close this discussion for good to avoid future risk to the exclusivity period. Similarly biosimilar interchangeability guidance may also suffer the change in the political environment. Most conservative circles want to limit interchangeability of biologics with biosimilars, and with strong biotech industry resistance, this may get delayed. However, it is unlikely to be avoided for long as interchangeability rules for biosimilars are all but certain under any administration.
- e-Cigarettes: This is another area where it can be contended that FDA over-extended its mandate by applying the same rules on e-cigarettes as to the conventional cigarettes. This rule has practically decimated the vapor industry which consists mostly of small mom-and-pop stores. It can be argued that e-cigarettes should not be regulated as other tobacco products, rather FDA should treat them similar to other parts of the world where e-cigarettes are considered less of a smoking product and more of a cessation product. This is probably a hard wish as the e-cigarette industry is not as organized as its big brothers in the tobacco industry. But it would not be a bad time to get FDA to revise its e-cigarette proposals.
- GMP and re-importation of drugs: Quality concerns have plagued drug supply chains for the last 5 years with numerous companies in India and China getting FDA Warning letters and Import alerts. While most of these issues have been limited to a small fraction of the manufacturers, it has been argued that FDA has not been able to fully implement GMP inspections due to political, logistical and financial limitations. The new administration is expected to have increasingly protectionist policies so it may be reasonable to assume that it would increase inspections and enforcement in non-US locations, particularly in India and China. The industry in those countries may wish to get more clarity in this direction. Increased enforcement is not necessarily a bad thing since it weeds out the bad players so the good ones may thrive. Increased enforcement will also alleviate the bad perception for imported drugs created due to the negative publicity generated by numerous Warning letters.
We don’t pretend to predict but in the spirit of the upcoming holiday season, wishes are the currency of the hopeful.
