The U.S. Food and Drug Administration has always concerned itself with competition in the marketplace, particularly with generic medicines, the head of the agency said Sept. 14.
It is just that now "we are being more vocal about it," Scott Gottlieb, commissioner of the FDA, said during a Washington policy forum hosted by Politico.
Even though the FDA is forbidden by law from considering the price of a medicine when approving it, Gottlieb acknowledged discussions about competition "always went on inside the agency."
Trying to facilitate more competition "is not a new view for FDA," he said. "The agency's policies were always geared towards more competition and facilitating more generic access."
The FDA chief declined to comment on the contents of a much-anticipated executive order from President Donald Trump aimed at reducing the costs of medical products — the subject of documents leaked earlier this year. Gottlieb directed all questions about the matter to the White House.
"A lot of what we are doing is independent, but the policies that we are formulating are hopefully going to be part of any kind of administration plan," Gottlieb said. "I'll leave it to the administration and the White House to articulate what a timetable or what an administration-wide plan may look like."
But Gottlieb noted that he has already revealed some elements of what the FDA is doing to help control drug costs, most of which revolves around speeding generic medicines to the market and knocking down impediments in their way.
"I'm not approaching it from the standpoint of drug prices, but drug competition, and trying to facilitate more competition in the market with the hope that that's going to eventually create the kind of environment that will lower prices," Gottlieb said. "And we think that the pricing environment speaks to the issue of access, and issues of access certainly is an issue of public health that ought to concern us."
Gottlieb noted that he recently announced the FDA was taking new steps to ease drugmakers' clinical development burden and lower their costs, which he said would in turn reduce the prices Americans pay for their medicines.
"You're just trying to import better science that's ideally going to yield a better answer as well as potentially make the process more efficient," he said.
Transparency
Another barrier to accessing lower-cost versions of medicines has been the misuse of required risk programs by brand-name drugmakers, in which the innovator companies try to claim they would be violating FDA regulations by selling samples of products to generic manufacturers for bioequivalent testing purposes, Gottlieb said.
He said the FDA would "very soon" be making public the letters the agency sends to branded companies explaining that no violations are being committed and they are free to sell the samples. Making the letters public would mean brand-name companies can no longer use such an excuse to delay generics.
Gottlieb first revealed in July that he was considering making such a move, although he emphasized then that the FDA would not release the letters as a "shaming vehicle" or simply because there was a commercial disagreement among branded and generic companies.
He said the FDA was looking broadly at other areas where it could be more transparent about information, such as possibly making rejection letters, known as complete response letters, public, although with some sensitive details redacted.
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He also said the FDA plans to soon make an announcement about making adverse event reporting data more accessible.
Regulations cleanup
Gottlieb also noted the FDA has been cleaning out and updating old regulations — a process he said would also help speed access to medicines.
What has happened too often at the FDA is that rather than issuing an updated regulation, the agency has tended to issue guidance that supersedes those rules and regulators have never withdrawn or tried to update the old regulations, he said.
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