Healthcare Business

FDA Lists Brand-Name Drugmakers That Obstruct Generic Development

All three drugmakers included in the Dow Jones industrial index were on a list of drug companies published Thursday by the U.S. Food and Drug Administration (FDA) alleged to have withheld samples of brand-name drugs from companies wanting to develop generic versions of the drugs. Merck & Co. Inc. (NYSE: MRK) and Johnson & Johnson (NYSE: JNJ) each dropped more than 1% while Pfizer Inc. (NYSE: PFE) posted a gain of less than 0.1% for the day.

The Dow companies were listed among dozens of generic and brand-name drugmakers about which complaints have been filed for refusing to provide samples of their products to generic drugmakers wanting to make copies of the brand-name drugs. Without the samples, generic makers cannot conduct testing to demonstrate that their products are bioequivalents to the brand-name drugs and apply for FDA approval.

FDA commissioner Scott Gottlieb, MD, issued a statement alongside the list of brand-name drugmakers “because we believe greater transparency will help reduce unnecessary hurdles to generic drug development and approval.”

The goal, according to Gottlieb, is to advance “policies that increase competition as a way to help make drugs more affordable and improve access.” Four complaints have been registered against Pfizer for refusing to supply samples of its Tikosyn heart arrhythmia treatment. Interestingly neither Merck nor Johnson & Johnson appeared on the list, but investors must have been wary of the FDA’s promise to “continue to look at more ways to expand upon today’s action and call public attention to situations where the careful balance that Congress sought between product innovation and access may be being disrupted.”

The list of complaints against specific companies and Dr. Gottlieb’s statement are available at the FDA website.