US FDA should make more company info public-report

The U.S. Food and Drug Administration should make public a wide array of information on products, including why it has refused to approve a drug or device, an agency task force said in a report released on Wednesday.

If adopted, the changes would shed considerable light on a review process that affects the entire drug and device industries. All of the proposals would offer the public more details on key agency decisions.

For example, the FDA Transparency Task Force recommended that the agency disclose “complete response” or refuse-to-file letters that explain why it has declined to approve a drug or refused to accept an application.

The agency should also publicly say when a company’s proposed drug application has been placed on hold, terminated, or withdrawn, it said in a report released on the FDA website (http://link.reuters.com/dyk25k).

Other proposals include:

* Expanding online public access to adverse event reports

* Disclosing or confirming the existence or nonexistence of investigational applications

* Disclosing when the FDA receives a new drug, biologic or device application

* Disclosing when unapproved applications are withdrawn and any significant safety concerns

* Disclosing when the agency declines to approve medical devices

* Disclosing safety and effectiveness summaries from pending applications in some cases

* Disclosing when the U.S. Justice Department seeks enforcement action on the FDA’s behalf

The FDA will take public comment for 60 days on the proposals before deciding whether to adopt them.

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WASHINGTON (Reuters)