FDALegislativeWatch

FDA Rejects “Not Approvable” Letters, Clarifies Efficacy Supplement

FDA says industry concerns about the implied finality of "not approvable" letters led it to change how it responds to drug applications.

Also in a ¹final rule published in the July 10 Federal Register, FDA clarifies the definition of efficacy supplement it included in its July 2004 proposed rule.

Starting Aug. 11, FDA will not issue "approvable" or "not approvable" letters when it declines to approve a drug. Instead, sponsors will receive "complete response" letters that say a drug review period has been completed and that the application is not ready for approval.

The final rule says the agency will describe "specific deficiencies" FDA has identified in an application and "when possible ... recommend actions that the applicant might take to place" a new drug application or abbreviated NDA "in condition for approval." The proposed rule had called for describing the needed changes when appropriate.

Congested OTC Monograph Process Can Leave Manufacturers Confused

The disparity between FDA's OTC monographs and up-to-date communications from the agency can create confusion for manufacturers, Office of New Drugs Director John Jenkins acknowledges.

At the Drug Information Association's conference in Boston June 26, Jenkins said the agency's consideration of changes to the pediatric cough/cold monograph points out the problems created by the unwieldy system.

Unlike changes to products approved under new drug applications, modifications to OTC monographs are bound by rulemaking requirements.

Behind-The-Counter Guidance Stalled, But Interest Grows To Expand Access

FDA executives say behind-the-counter status for nonprescription drugs resonates in discussions at the agency, but a former deputy commissioner says the agency's BTC interests are stifled by not having explicit authority.

Scott Gottlieb, a former FDA deputy commissioner for medical and scientific affairs, said agency officials have worked on a BTC status guidance to facilitate switching some prescription drugs to OTC.

However, questions about authorities the agency gained under the FDA Amendments Act of 2007 have kept the guidance under wraps, he said.

FDA Right On Risk Approach, Slow On Food Protection Progress – GAO

The Government Accountability Office cites significant cost savings in its endorsement of FDA's risk-based approach to import safety inspections, but says the agency has yet to deliver on plans for tightening its protection of the U.S. food supply.

In a June 12 report, GAO concludes a risk-based approach to import safety appears to be an "efficient and effective" use of "scarce resources."

GAO estimates it would cost FDA $524 million for one-time inspections of the 65,500 domestic food firms and $3.16 billion to inspect the 189,000 registered foreign facilities.

Increased FDA Authority Over OTCs Sought in Waxman Bill

The Non-Prescription Drug Modernization Act, introduced Nov. 6, would give FDA authority to quickly amend or repeal OTC drug monographs without being required to pursue notice and comment rulemaking as currently required under the Administrative Procedures Act.

FDA Reauthorization Steers Clear Of Agency's OTC Authority, DSHEA, AER Law

The FDA reauthorization bill Congress has passed does not rock the boat on FDA's current authority over either over-the-counter switches or dietary supplements.