FDA seeks speedier approval of generics

Food and Drug Commissioner Scott Gottlieb, MD, said the agency will tackle rising prescription drug costs by encouraging development of generic versions of complex drugs and drug-device combinations.

Gottlieb said in a FDA blog post these treatments are more difficult to copy and biosimilar manufacturers may not even try developing their own versions, unlike individual pills which normally see generic competition right after the original patent expires.

To ease this process, the FDA released two draft guidance documents: one to assist abbreviated new drug applications (ANDAs) with their pre-meeting requests and materials, and another to help submissions of ANDAs for complex products known as peptides. Gottlieb wrote in his blog post that more guidance documents should be coming in the near future.

“But we know that better guidance isn’t the only answer,” he wrote. “Some drugs lack generic competition because they cannot be measured through traditional in vivo bioequivalence methods and there’s no efficient and convincing bioequivalence test method available. In these instances, an applicant needs to conduct more extensive clinical endpoint testing to show bioequivalence of a generic drug to a brand-name drug. This can be burdensome and discourage generic product development.”

Lowering pharmaceutical costs has been labeled a priority by both Republicans and Democrats, though they disagree on the solutions. Republicans generally favor increased competition through generic alternatives, while Democrats have proposed greater federal control of prices, like allowing price negotiation in Medicare Part D, and allowing certain prescription drugs to be imported from overseas.

To the pharmaceutical companies, the policy shift either way will be significant.

“This is a shot across the bow” to the brand name companies, analyst Steve Brozak, president of WBB Securities, said to the Associated Press.