FDA Assists Generic Drugmakers with New Guidances

When the FDA committed to helping generic drug manufacturers apply for drug approvals, the agency said it would also streamline the priority reviews and risk documentation required for generic drugs. To that end, the FDA is expanding generic competition and has issued new guidance on Risk Evaluation and Mitigation Strategies (REMS).

"Earlier this year, we made changes to how we prioritize the agency’s generic drug submissions. The goal was to prioritize the review of generic applications until the FDA has approved three generic versions of each particular drug," said FDA Commissioner Scott Gottlieb, MD, in a statement. "We’re expanding this competition-focused policy to prioritize any application that can meet the FDA’s approval standards at the point when the 180-day exclusivity period expires on a first generic entrant to a branded medicine."

In addition, FDA wants to create equality between brand and generic drug manufacturers on REMS, the documentation that ensure that the benefits of a drug outweigh its risks.

Current law requires that branded and generic companies try to reach agreement on the implementation of a single, shared system REMS, rather than maintaining separate ones for the branded drug and its generic competitor. These negotiations can take months or years. Gottlieb said, in a statement about FDA’s new REMS guidance, that he believes that brand drugmakers "sometimes use these negotiations strategically, as a way to slow generic competitors.”

The agency’s new draft guidance, "Use of a Drug Master File for Shared System REMS Submissions," explains how manufacturers can submit collective sets of files to the FDA that represent all participating firms.

Currently, under a shared system REMS, multiple applicants need to coordinate the submission of identical REMS-related documents for their respective applications. The new process will eliminate the need for each manufacturer to submit files individually, eliminates duplicative paperwork for sponsors, and will decrease the volume of forms the FDA’s reviewers must assess, Gottlieb said.

While Allen Goldberg, Vice President of Communications for the Association for Accessible Medicines (AAM), praised FDA’s action on REMS, he said further steps are required to level the playing field between generic and brand drug manufacturers.

“We appreciate FDA’s continued focus on the anticompetitive tactics used by brand companies to thwart generic competition. While this guidance is a positive step forward, there is no question that legislation like the CREATES Act is necessary to stop the constant abuses of FDA’s safety programs,” Goldberg told Drug Topics. “Unless strong action by Congress is taken, brand companies will continue to manipulate the system and delay or thwart generics from reaching patients.” The CREATES Act is the Creating and Restoring Equal Access to Equivalent Samples Act.

Gottlieb also said that FDA will be looking more specifically at addressing situations where innovator firms may be leveraging the REMS requirements to block or delay generic competition. “Because of the impact of generic entry on a brand company’s market share, brand companies often have an incentive to prolong these negotiations or refuse to agree to a single, shared system REMS. In addition to delaying generic drug approval, these negotiations are time- and resource- intensive for both industry and the FDA,” Gottlieb said. “This is not in the best interest of public health. Not only is the approval of a generic competitor delayed, but also the drug approval process is less efficient.”

In October, FDA issued a draft guidance to assist generic drug manufacturers on applying for drug approvals.

“The creation of a more efficient path for the development and approval of generic drugs is a critical component of our efforts to promote competition and increase access to affordable medications,” Gottlieb wrote in a FDA Voice blog post. "By providing greater clarity and direction to prospective drug applicants, we hope to help reduce the cost and barriers to bringing new generic medicines to patients.”