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Drug and device makers could seek big changes in how they’re overseen by the FDA, which asked Sept. 7 for comments on how to implement President Donald Trump’s push to cut federal regulations.
The FDA’s actions could have huge ramifications for companies in the pharmaceutical, medical device, and biologics industries like Pfizer Inc. and Johnson & Johnson, given the comments will guide the agency in deciding which regulations to change or cancel and which to keep. Neither industry giant was available to comment to Bloomberg BNA on the FDA’s efforts.
The Food and Drug Administration issued four notices asking the public to identify regulations it could modify, repeal, or replace in response to a Trump administration effort to reduce the high cost of regulatory burdens. In January, Trump issued an executive order requiring agencies to identify two regulations to cut for each new one they propose and to offset the costs of new regulations. He also issued an order requiring that agencies figure out how to implement those plans.
In a blog post, Deputy Commissioner for Policy, Planning, Legislation, and Analysis Anna Abram said FDA-regulated products account for 20 percent of consumer spending each year. And FDA regulations take up more than 4,000 Code of Federal Regulations pages, she noted.
The FDA asked for input in separate notices for its drug, medical device, and biologics offices, and issued another one for the rest of the agency. It is asking commenters to consider, for example, whether a regulation is outdated, hard to comply with, demands requirements already covered by industry standards, or imposes needless paperwork and reporting burdens. The FDA wants feedback from patients, consumers, health-care providers, and the public, private, and nonprofit sectors.
Fulfilling Trump’s orders will be tough on agencies: About half of federal regulations are mandated by statute, and eliminating one requires time-consuming compliance with procedures set by law. But the FDA’s Abram said in her blog post a review is necessary to keep up with the times.
"[O]ur 100-plus-year history lends itself to a closer examination of the regulations that have guided our work,” she said. “Some have been in place for decades, and may not reflect the most up-to-date approach to achieving our public health mission.”
She highlighted generic drug competition as an example.
"[W]e’re looking at places where FDA’s rules concerning new drugs are being used in ways that may create obstacles to the timely entry of generic competition,” Abram said. “We want to make sure our policies aren’t being misused in ways that thwart the competition that Congress intended when it created the modern generic drug framework.”
The Biotechnology Innovation Organization (BIO), a trade association representing biotech companies and institutions, said it welcomes the FDA’s effort and will contribute comments.
“We applaud the FDA for soliciting ideas on how to streamline and modernize regulatory requirements to ensure safe and timely delivery of effective therapies,” the organization said in a statement to Bloomberg BNA. “We believe there are a number of common sense steps the [a]gency could pursue that would promote market efficiency and competition while maintaining the integrity of the systems governing drug approval and patient access to prescribed medicines.”
The Pharmaceutical Research and Manufacturers of America said through a spokesman it is reviewing regulations that may fall under the agency’s request. The Food and Drug Law Institute didn’t have a comment.
However, Public Citizen Regulatory Policy Advocate Amit Narang told Bloomberg BNA in an interview the FDA notices contain “boilerplate” language other agencies are using to conduct what he argued is a “one-sided, rather than balanced” review.
“Our general view on this is that it doesn’t look like they’re looking for ways in which they can strengthen regulations to protect patients,” he said.
Narang said the Obama administration also undertook a government-wide effort to remove unnecessary or outdated regulations. Because that effort already cleared out “the low-hanging fruit,” he said, it will be harder for the FDA to identify what else to cut.
As a result, “this effort is really going to be focused on newer rules FDA issued under Obama” that have not been in place long enough to see if they work, he said.
Carol Pratt, a partner with Lee & Hayes PLLC’s chemical and life sciences group and a Bloomberg BNA advisory board member, said she suspects the FDA’s effort won’t yield much.
“It is hard to imagine what FDA is going to do with the information it receives,” she said. “This is a real scattershot approach that is not likely to identify consensus for removing any particular regulations. However, the gesture gives the appearance that the FDA is acting in good faith to implement Trump’s mandate.”
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