FDA Solicitation Of Industry Input Prior To Draft Guidances Urged By PhRMA

FDA should seek counsel from drug manufacturers before issuing draft guidances, the Pharmaceutical Research & Manufacturers of America suggests in recent comments to the agency on the implementation of Good Guidance Practice provisions included in the FDA Modernization Act.

"FDA should solicit outside input before the agency has solidified its views into even a draft approach for a new guidance," PhRMA says, suggesting meetings, workshops, advisory panels and other means for obtaining public opinion should be used as early as possible in the guidance development process.

Under FDAMA Sec. 405, FDA is required to review its Good Guidance Practice policy and issue new regulations by July 1, 2001.

"Consultation with the public and the regulated industry may avoid instances of 'FDA-proposed solutions' reappearing in subsequent guidances after they have been determined to be inappropriate in a prior guidance," the association suggests.

PhRMA points to FDA's draft guidance on topical dosage forms as an example of a discarded consideration that resurfaced in a subsequent document. The draft includes a proposal from FDA that an in vitro release method be used for the assessment of bioavailability and bioequivalence - an idea that had been proposed in an earlier guidance but rejected because it did not achieve scientific consensus (¹ (Also see "NutraMax Extends First Aid Line With Triple Antibiotic Bandages" - Pink Sheet, 30 Nov, 1998.)).

When FDA decides to deviate from an existing guidance document, it should offer the opportunity for a meeting with the sponsor, PhRMA adds. The agency also should "provide a sponsor timely written notice" stating the agency's reasoning for the change.

A written statement regarding the action "will add clarity and transparency to the process and help ensure that the agency only deviates from existing policy for good cause," PhRMA maintains.

Drug manufacturers should be informed when FDA is considering developing a new guidance or revising an existing one so that interested parties can advise the agency on whether the proposed changes constitute "significant" or "minor" changes in policy, PhRMA recommends.

"In many instances, affected stakeholders will have a better sense of the significance of a new policy than FDA," the association comments.

In issuing guidances, FDA distinguishes between those expected to involve a minor change versus a significant change. Guidances expected to involve a significant change are released in draft form for comment prior to implementation.

PhRMA stresses the importance of properly categorizing guidances, saying, "no matter how extensive the mechanisms that FDA establishes for prior public participation in the development of significant guidance documents, those documents will do no good if FDA does not properly distinguish" between guidances that need to be issued for comment and those that do not.

"At a minimum," PhRMA suggests, "after FDA has published a 'minor' guidance, FDA should allow the public to petition the agency to recategorize" the guidance and "stay implementation of the guidance until the public has had an opportunity to comment."

PhRMA reminds the agency that FDAMA Sec. 405 discourages policymaking through informal mechanisms such as letters, speeches or statements at public meetings.

Under Sec. 405, a company should not expect "FDA to announce in a warning letter for the first time that a company is in violation of applicable Good Manufacturing Practices because the company has failed to do something that FDA has never previously said in regulations or guidances that the company should be doing," the industry group states.

PhRMA maintains, "regulated entities should be safe in not following such informal pronouncements by FDA staff....Indeed, a notice of inspectional observation should be retracted if it is not based on an existing regulation or guidance document."

The comments were prepared by PhRMA's Good Guidance Practices Workgroup, chaired by Zeneca VP-Drug and Regulatory Affairs William Kennedy, PhD.