US drug regulators are getting ready to take a close look at the regulation of generic drugs, including new policies recently proposed by the US Food and Drug Administration (FDA) and areas that could stand to benefit from additional regulation.

Background

In a new Federal Register notice posted on 18 August 2014, FDA said it will soon hold a meeting to focus on the implementation of the Generic Drug User Fee Act (GDUFA), a program passed as part of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) intended to improve FDA's regulatory capacity by authorizing it to collect user fees from members of the generic pharmaceutical industry. In return, FDA committed to making improvements to not just the pace at which it approves generic drugs—which have experienced notorious backlogs in recent years—but also to the policies and regulatory science it uses to approve generic drugs.

Guidances to be Discussed

Since FDASIA was signed into law, FDA has released three guidance documents intended to clarify aspects of the generic drug process:

• ANDA Submissions—Content and Format of ANDAs
• ANDA Submissions—Amendments and Easily Correctable Deficiencies Under GDUFA
• ANDA Submissions—Prior Approval Supplements Under GDUFA

Two other documents have apparently already been finished, but have not yet been released by the agency:

• ANDA Submissions—Refuse to Receive for Lack of Proper Justification of Impurity Limits
• Controlled Correspondence Related to Generic Drug Development

Both documents will presumably be released by FDA by the time it holds its 3 September 2014 meeting, as both documents—as well as the three other guidances—will be discussed at FDA's meeting.

FDA's notice also indicated that it's interested in hearing what more it can do to facilitate the development of new guidance documents to help the generic drug industry.

Asked FDA:

• "What other GDUFA implementation topics need the development of guidance?"
• "Are there any topics or issues related to generic drug development other than those related to GDUFA implementation that need the development of guidance?"

The agency has previously asked similar questions of the industry.

180-Day Exclusivity in the Spotlight

Notably, FDA also said it will be "seeking input on possible processes FDA might introduce under GDUFA for making determinations on 180-day exclusivity," which is now used to grant a period of exclusive marketing rights for the first company to successfully file a challenge to a patented medicine.

FDA said it is considering making that process "public," allowing for more open consideration of whether an applicant might have forfeited their exclusivity rights. Under Section 505(j)(5)(D) of the Federal Food, Drug and Cosmetic Act, a 180-day exclusivity period may be forfeited if a company fails to market an approved drug within 75 days of approval, within 30 months of the date of application, or fails to obtain tentative approval, among other reasons.

FDA said it's also interested in hearing if there are any alternate legal or regulatory mechanisms that could be used "to better facilitate FDA's determination of and orderly resolution of sponsors' challenges to 180-day exclusivity determinations." The current process is so expedited as to be "inconvenient," FDA said.

The agency is also considering a new guidance document on the 180-day exclusivity process, it said.

Federal Register

More: FDA Law Blog

More: FDA's Generic Drug Regulatory Science Program