Are you a medical device manufacturer getting ready to start a clinical trial or submit notification or approval requests to the FDA? Hang on to your hat.
President Trump is a man of his word when it comes to his campaign promises to cut government regulations. On January 30, 2017, he signed an executive order (EO) which is creating great uncertainty with the FDA and device industry.
“One In, Two Out” Regulation Order
The EO, dubbed, “one in, two out,” requires all government agencies, except the military or national security branches, to eliminate two regulations for every new regulation instituted. The EO also gives the White House Office of Management and Budget (OMB), authority to exempt other agencies.
The FDA would most certainly seek exemptions from the OMB. It’s also likely to make regulatory affairs directors at device companies pull out their hair.
Zachary Brennan wrote on the RAPS (Regulatory Affairs Professional Society) blog on January 30 that no one knows how such a plan would work for a public health mission like the FDA, “particularly as most regulations are not necessarily intertwined. So if the agency needed to put in place a new regulation, it would then have to presumably cut out two other, unrelated regulations linked to public health.
“According to the text of the EO, this plan will likely apply to FDA guidance documents too, which will be a problem for pharmaceutical and medical device companies that rely on such guidance to understand how FDA interprets the law.”
For example, noted Brennan, if the FDA wanted to finalize guidance on how companies can use multiple endpoints in clinical trials, the agency would then presumably have to identify two other regulations unrelated to clinical trials that it would need to eliminate. And those decisions on what to cut and what to add would also be reviewed by the White House, according to officials, who added that the new EO sets a budget of $0 for new regulations in 2017.
On whether the EO applies to FDA guidance documents, a White House spokesman told Brennan via email: “A guidance from OMB is forthcoming.”
The OMB Director will issue, “processes for standardizing the measurement and estimation of regulatory costs; standards for determining what qualifies as new and offsetting regulations; standards for determining the costs of existing regulations that are considered for elimination; processes for accounting for costs in different fiscal years; methods to oversee the issuance of rules with costs offset by savings at different times or different agencies; and emergencies and other circumstances that might justify individual waivers of the requirements.”
FDA Hiring Freeze and Industry Fees
As the FDA figures out if it will be exempt from the new “one in, two out” rule, industry regulatory leaders will be doing their best to recast the industry’s importance as a national security or public safety concern after a Trump hiring freeze was announced. How will that freeze impact FDA officials hired from user fee funds collected from industry?
The White House told Brennan, “The fact that FDA is funded by user fees does not in and of itself exempt the FDA from being subject to the Hiring Freeze Memorandum since the hiring freeze applies to all executive departments and agencies regardless of the sources of their operational and programmatic funding. That said, the FDA’s user fee supported work could be subject to public safety and national security exemptions provided for by the memorandum.”
Radio Silence With Congress
Meetings between FDA and congressional staffers on the user fee agreements have reportedly had to be cancelled as the Trump Administration has called on agencies to halt all correspondence with Congress.
Michael Gaba, a life science partner at Holland & Knight law firm, reportedly said Trump’s executive order was broadly written and gives the director of the OMB latitude in how to implement it.
“There is discretion on how you evaluate the cost of old and new regulations,” Gaba said. “Before we can really analyze this we need to see what the OMB director says.”
The first three moves by the Trump White House related to medical device makers are going to take a while to digest. For now, it’s just plain indigestion.
