Quicker Generic Approvals, Less Litigation Among Goals of FDA Rule

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By Bronwyn Mixter

Oct. 5 — A new final rule on generic drug applications aims to speed approvals and cut unnecessary litigation, the FDA said Oct. 5.

The rule (RIN:0910-AF97) also intends to bring “business certainty” to both generic and branded drugmakers, the Food and Drug Administration said.

The rule implements portions of a 2003 Medicare drug law and governs approval of abbreviated new drug applications (ANDAs) and 505(b)(2) applications. ANDAs are used for generic drug approvals, while 505(b)(2) is a type of abbreviated pathway that allows the FDA to rely on data not developed by the applicant for approval of a new drug application.

The rule, which will be published Oct. 6 in the Federal Register, also governs the submission of certain drug patent information.

The 2003 Medicare law, the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), addressed key concerns identified in a Federal Trade Commission report on anticompetitive strategies that could delay access to generic drugs, the FDA said. The final rule comes out as policymakers are focusing on concerns about drug costs and the lack of cheaper competition, including generics, for certain products.

Branded Drug Indications

Gaby L. Longsworth, a patent attorney with Sterne Kessler Goldstein & Fox, an intellectual property law firm in Washington, told Bloomberg BNA that the most significant provision in the final rule is that it “clarifies requirements to address overbroad and ambiguous use codes that may delay approval of generic drugs.”

A use code is the new drug application holder's description of the specific approved method of use claimed by the patent required for publication in the FDA's Orange Book. The Orange Book, formally titled Approved Drug Products with Therapeutic Equivalence Evaluations, lists patents submitted to the agency by branded drug companies as covering a branded drug or its use.

The FDA said the clarification in the final rule is intended to help the agency implement statutory provisions that permit 505(b)(2) and ANDA applicants to omit protected conditions of use from their labeling and obtain approval for conditions of use that aren't covered by unexpired patents or exclusivity.

“The revisions to the use code provisions are long overdue, but it remains to be seen whether they will have any teeth,” Longsworth said.

Patent Challenges

The rule also establishes a date (the first working day after the day the patent is published in the Orange Book) before which an ANDA applicant cannot send valid notice of a paragraph IV certification to a newly listed patent owner, Longsworth said. Paragraph IVs are certifications challenging the patent on a drug.

The final rule also addresses scenarios in which a 30-month stay may be terminated, Longsworth said. Under the Hatch-Waxman Act, a Paragraph IV certification triggers a statutory 30-month stay of approval of the ANDA/generic drug.

Generic Marketing Exclusivity

Longsworth also said the rule defines the “first commercial marketing” date for purposes of the 180-day period of generic drug exclusivity.

The first generic drug applicant to file a Paragraph IV certification is entitled to 180 days of generic marketing exclusivity.

The FDA said in the final rule that the first generic drug applicant is required to notify the FDA within 30 days of the date of first commercial marketing of the drug product. The agency said that if a first applicant doesn't notify the FDA within this time frame, it is “deeming the date of first commercial marketing to be the date of the drug product's approval,” which is when the 180-day period would begin.

A spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA) told Bloomberg BNA that PhRMA is reviewing the final rule.

The Generic Pharmaceutical Association (GPhA) didn't return a request for comment on the rule.

The proposed version of the rule was issued in February 2015, with comments due in June of that year.

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The final rule is at http://src.bna.com/i9P.

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