Would a Defanged FDA Be Good for the Pharma Industry?
Speculation about how the FDA will change under the Trump administration is top-of-mind for every pharma professional today. Everyone from regulatory affairs personnel and product safety managers to marketing folks and compliance experts are wondering what’s next.
Two of the main issues are how Trump’s regulatory reform efforts will affect the FDA and, consequently, the industries it regulates; and what the drug industry can expect from an FDA led by Commissioner Dr. Scott Gottlieb.
While Trump’s federal hiring freeze was lifted in April, he continued pushing his regulatory reform agenda by ordering federal agencies to withdraw certain regulations and limit issuance of others. In March, the president issued an executive order requiring federal agencies to establish reform task forces and setting regulatory reform officers to work in identifying regs ripe for the chopping block.
After that, the OMB issued guidance that requires agencies to submit workforce reduction plans by this September, noting that it will start monitoring their progress in February 2018. Of course, since FDA is part of the Department of Health & Human Services, it’s unclear how this EO will affect the FDA – that is likely up to HHS and its new chief, Tom Price. Trump had singled out the FDA in comments earlier in the year, telling pharma industry CEOs that 75 to 80% of FDA regs would be eliminated on his watch, according to the Regulatory Affairs Professionals Society.
Overhauling the FDA
It’s not hard to imagine that Trump’s promise to overhaul the FDA could result in accelerating drug and device approvals. While many of the ideas he’s mentioned – such as eliminating regulations and cutting requirements to demonstrate pre-market effectiveness – would require Congress to act, his pick to head the FDA, has already voiced support for reducing review times for medical products.
Gottlieb is former deputy commissioner at the FDA, as well as a physician and businessman with deep ties to the pharmaceutical industry. For his confirmation hearing in May, Gottlieb’s statement noted that the FDA’s FY 2018 budget includes an increase in user fees that would finance the FDA’s pre-market review process which will “dramatically increase the agency’s capacity for pre-market review, and bring more new products to market faster than ever before.”
The resulting speed vs. safety argument is now underway, and pharma companies are watching closely to see how it will play out. While fewer regulations may sound like a good thing to the industry, there are potential risks of deregulation for drugs and other FDA regulated products, including ethical concerns.
Get the DL on Dereg
Pharma industry insider Norma Skolnik addressed these two key issues – and others – in a recent audio conference for AudioEducator, “The Trump Administration and the FDA’s New Commissioner.” From changes in the works at the FDA and what can be expected from Commissioner Gottlieb, to how new HHS Secretary Price will impact the industry, Norma covered all the outstanding questions that pharma professionals are mulling in these uncertain times.
To find out more about what’s in store, including the impact of Trump’s deregulation task force and budget cuts, as well as Gottlieb’s intention to ease drug regulations, streamline the FDA and speed the drug approval process.