Attacking drug shortages
The Federal Trade Commission paved the way for a generic-drugmakers trade group to implement a plan to supply the Food and Drug Administration with manufacturing data as part of a government effort to address drug shortages.
FTC officials penned an 11-page opinion letter last week saying the agency won’t challenge the Generic Pharmaceutical Association’s proposed initiative, which involves pooling data from a number of pharmaceutical companies and then sending it to the FDA. Though the FTC had scrutinized the plan for potential antitrust issues that could stem from pharmaceutical competitors gaining access to sensitive manufacturing data gathered through the initiative, the agency concluded that the plan “is not likely to harm competition.”
GPhA proposed employing an independent third party to collect and send the data to the FDA to ensure no other party, including GPhA, would access that information. That safeguard and others quelled the FTC’s antitrust concerns.
The FTC’s Bureau of Competition has “no present intention to bring an enforcement action to challenge GPhA’s proposed ARI program if it is implemented as described and the safeguards it contains are adhered to in practice,” according to the letter signed by FTC Assistant Director Markus Meier.
With that announcement, the plan’s rollout should come soon, said David Gaugh, a senior vice president with the GPHA. Gaugh called the FTC’S action a huge positive. The program also will extend to pharmaceutical companies that aren’t association members.
“We do have a few things that we need to flush out, and we are working with the FDA,” Gaugh said. “I couldn’t pinpoint a date, but within the coming weeks.”
GPHA selected Parsippany, N.J.-headquartered IMS Health as the third party that will review the data. IMS intends to collect data from drug companies about their projected and current production and supply schedules. The program initially will focus on accelerating the production and availability of critical drugs that are in short supply, defined as drugs expected to be in shortage for more than 90 days without a therapeutic alternative, according to the American Society of HealthSystem Pharmacists. The program could eventually expand to assist FDA officials in working to prevent potential shortages.