Healthy Skepticism Library item: 19748

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Publication type: Journal Article

More in-house reforms at FDA
Scrip 1995 Dec 1;

Full text:

The US FDA, perhaps attempting to stay a step ahead of its conservative critics in Washington, has announced further reforms intended to “reduce the regulatory burden, primarily for pharmaceutical manufacturers.” (Changes to harmonise biologics regulations with those for synthetic drugs were announced earlier this month; Scrip No 2078, p 18).

…scientific/educational materials
The most significant of the new policy changes involves a topic that has given the agency much legal and political grief in the past year – restrictions on the distribution of scientific and educational materials by drug manufacturers to physicians. Under its new policy, the agency will permit drug sponsors to disseminate certain textbooks and journal articles in marketing their drugs to healthcare professionals, even if they include information on unapproved uses.

“Although drug and device companies are not permitted to promote unapproved uses of FDA-approved products, FDA has determined that distribution of certain textbooks that do not highlight unapproved uses should be permitted,” the agency announced. An FDA policy staffer told Scrip that this would apply only to independently published free from industry influence in their editing and content.

Manufacturers will also be allowed to distribute “certain peer-reviewed journal reports upon which FDA relied for approval of a product… even if they contain information (eg reference to unapproved uses) that is inconsistent with the FDA-approved labelling.” The policy will allow reprints of studies used as the basis of NDA approval to be circulated, although doctors will have to be notified, perhaps by a sticker on the front of the reprint, of any discrepancies between the uses discussed in the article and those in the labelling.

The announcement amounts to a softening of the agency’s stance on promotional use of these materials. It is unlikely to halt the Congressional moves toward more fundamental FDA reform, but it did appear to fend off one agency critic, House oversight subcommittee chairman Joe Barton, who cancelled a late November hearing on “FDA censorship” (referring to its rules on advertising and promotion).

The Washington Legal Foundation’s First Amendment lawsuit, which challenges the FDA’s draft policy on industry sponsorship of scientific and educational activities, also seeks a moratorium on all FDA regulation of journal reprint and textbook distribution. The conservative group has argued that greater public good would result from free dissemination of such materials to physicians, without regulatory restriction.

The FDA’s carefully worded announced clearly falls short of this goal. It addresses only the use of these materials in direct marketing to physicians. Dissemination of information on unapproved uses within the broader context of scientific and educational conferences and other activities would still be regulated under the draft CME policy, which the agency is currently finalising.

The new policy on journal reprints and textbooks will be published shortly in draft form in the Federal Register. The agency says it will have a notice-and-comment period of only 30 days, to help expedite a final policy which it says is supported by the pharmaceutical industry.

…IND guidances
The FDA also announced initiatives to streamline IND regulations. It plans to issue a new guidance document detailing its willingness to accept summary toxicology findings based upon “unaudited, draft toxicology reports of completed studies.” The document will also describe the specific manufacturing data required for initial investigation of a drug in human subjects. Public comment will be sought on the guidance, but it will be implemented immediately.

A new Manual of Policies and Procedures will be issued to revise internal procedures related to the oversight of IND submissions. As previously announced, these revisions will speed up the FDA’s responses to sponsors whose products have been placed on clinical hold.

Another initiative is a notice, to be published in the first quarter of 1996, seeking public comments on whether the FDA should create a special single-dose IND with limited data requirements, and reduce or eliminate IND submission requirements for individual investigators using products previously approved for advanced human testing.

In addition, two new guidances will be published detailing the changes in manufacturing and environmental assessment requirements announced in April (Scrip No 2016, p 21).