FDA Approval (or Denial) Info Coming to the Web?

The FDA wants to change the way it shares information with the public about device approvals.

On December 16, 2019, the agency put out a 16-page proposal to end its practice of publishing quarterly lists of approval or denial decisions for premarket approval applications (PMAs) and humanitarian device exemptions (HDEs) in the Federal Register.

The Food and Drug Act does not require the agency to publish this information in the Federal Register, but the agency has been doing this since the 1980s.

The agency would continue to publish the same information, along with summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit for HDEs on its website. The public can then request the review of PMA and HDE decisions and the 30-day period for requesting reconsiderations will begin when notice of a decision is placed on its website.

The agency said it costs about $1,000 a year to publish in the Federal Register. The change would allow FDA staff to “focus on other agency priorities.” The agency is frequently criticized (fairly and unfairly) for how long it takes to approve devices. If reducing the amount of public information on this topic is of concern to readers, you should offer comments by January 15, 2020.

Freedom of Information Changes

The agency is also proposing to revise regulations for requesting copies of current PMA approvals, denials and SSEDs to direct requests to the agency’s Freedom of Information staff rather than the Division of Dockets Management.

We don’t know if this proposal will improve agency transparency. Thomas Susman, director of the American Bar Association (ABA) Governmental Affairs Office, helped amend the Freedom of Information Act (FOIA) as a congressional staffer in the 1970s. In an ABA article last August, Susman said, “A major problem with FOIA is that fewer resources are devoted to processing requests, resulting in longer waits and backlogs.”

According to the ABA, the feds are falling farther and farther behind in processing FOIA requests. In 2017, the government received 789,000 requests, but processed only 760,000.

In the same ABA article, Drew Shenkman, assistant general counsel at CNN stated the FOIA laws “are not very effective. It’s very difficult to use them to do basic newsgathering.”

The agency is proposing that any final rule based on this proposed rule become effective 30 days after the date of its publication in, you guessed it, the Federal Register.

Click here if you want to submit comments to the agency.