A recent White House oversight policy change could gum up the FDA’s day-to-day work and hurt industry’s ability to stay in compliance, lawyers told Bloomberg Law.
A White House memo released this month concluded the Congressional Review Act gives more discretion to its Office of Management and Budget over regulatory agencies than previously thought. The statute outlines what sorts of agency rules and documents are subject to executive branch oversight.
Among documents that will require more scrutiny are Food and Drug Administration guidance documents, which drug and device companies rely on to steer their regulatory and clinical trial compliance priorities. Starting May 11, the FDA is required to analyze its regulatory guidance recommendations to decide if they’re costly enough to merit additional review by the OMB.
Right now the agency has to do that for regulations, which have the force of law and carry penalties or fines for noncompliance.
Requiring the FDA to do a similar analysis for guidance documents, which unlike regulations don’t have enforceable requirements, could slow agency efforts to guide the industry on proper procedures.
Agency employees are worried about the change and are pushing for exemptions to the new interpretation to exclude these types of documents, according to an FDA consultant who used to work at the agency.
“Advocacy organizations and patient groups are also planning on sending the White House a request this Friday to exempt the FDA from the new interpretation,” Ryan Hohman, vice president at the health care advocacy group Friends of Cancer Research, said.
Hohman said he doubts whether the OMB would “have the bandwidth to review the type of very in-depth science-based documents in a way that would provide any benefit to the guidance process.”
A senior OMB official said the memo will have no effect on drug approvals. The memo includes language that allows the OMB to “identify categories of rules that are presumptively not major” and won’t be subject to review, which means “that many agency guidance documents or whole categories will not require analysis to demonstrate they are not major,” the official said. He also noted that under the current Congressional Review Act there is “no authority to provide exemptions to the law.”
The policy change is part of a larger push by the Trump administration to claw back what it considers burdensome regulations.
“The sense is that guidance documents are in many cases ways of creating new requirements or new expectations,” Aaron L. Josephson, a senior director at Mintz who specializes in health-care policy and regulatory compliance, said. They aren’t legal requirements but are often followed by the industry as if they were.
“The administration wants to cut down on those types of expectations across the board,” Josephson said, and creating more hurdles for agencies is one way of doing that.
It’s difficult to know how big an impact this new interpretation will have on the FDA because it’s hard to know what future guidance documents will be considered “major” and therefore have to be sent to the OMB for review, Josephson said. Something is considered “major” when it would cost the economy $100 million or more.
Sally Katzen, who worked at the OMB during the Clinton administration, doesn’t think the interpretation’s inclusion of guidance documents will have a major effect on the FDA’s day-to-day activities. “If we are talking about guidance for a specific product or a particular protocol, it would likely not be considered major guidance and thus not likely covered,” she said.
Josephson said he isn’t convinced the expanded Congressional Review Act interpretation would have a huge affect on the FDA or the drug industry overall in the short term. But small companies that don’t have lots of lawyers on retainer or huge regulatory compliance offices would feel the brunt of any FDA advice slowdown, he said.
“Typically deregulation is spun as ‘well we’re helping small businesses avoid over-burdensome agency actions,’ but in this case small businesses like getting the FDA’s thoughts on policy,” he said.