The US Federal Trade Commission (FTC) has said it will not seek to challenge an initiative proposed by the Generic Pharmaceutical Association (GPhA) to tackle the nation's "unprecedented increase in shortages of critically important medications."
The GPhA's proposed programme, called the Accelerated Recovery Initiative (ARI), would provide the Food and Drug Administration (FDA) with information which would, says the industry group, enable the agency staff "more efficiently and effectively to accelerate the recovery of critical drugs in short supply."
A key element of the ARI is an agreement among drug manufacturers to pool competitively-sensitive production information about products in short supply. Because of this agreement, the ARI would raise substantial antitrust concerns if this information were to be shared among competitors, because such information could facilitate collusion among drug manufacturers, an advisory opinion issued by the FTC's Bureau of Competition staff points out.
However, the Bureau staff also say they have concluded that GPhA has designed the programme to safeguard competitively-sensitive information and to limit the potential that the ARI might result in harm to competition.Among other things, GPhA has selected an Independent Third Party (ITP) to collect and transmit the data to the FDA, and no other party - including GPhA - will have access to the information or any analysis derived from it, the advisory opinion notes.
The ITP selected by GPhA for the programme is IMS Health. The firm will play a crucial role in assisting FDA with a more accurate, timely and comprehensive view of current and potential drug shortage situations, and in establishing practices to lessen or eliminate the impact of a current shortage, says GPhA."As an established industry leader with decades of experience, IMS is ideally suited to fill this critical role," noted GPhA chief executive Ralph Neas.
"IMS commands the respect of all stakeholders and has a reputation for confidentiality. Their unique ability to collect, process and communicate the complex manufacturing data the ARI requires will be essential to the initiative's success, and will strengthen the entire health industry's collective ability to increase communication and supply patients with the medicines they need," he said.
Specifically, the ARI is predicated on voluntary communication between the FDA, IMS and stakeholders involved in the manufacture and distribution of critical generic drugs currently in short supply. It is designed to use real-time supply and distribution information gathered by IMS, as well as manufacturers' production and release forecasts, to determine current and potential supply gaps, with a focus on products for which a shortage is expected to last longer than 90 days. The ARI also calls for a high-level SWAT (special weapons and tactics) team to be formed within the FDA with the ability to respond quickly to critical shortages and work with the current Drug Shortage Staff expanded through President Barack Obama's drug shortage initiative.
"The ARI will maintain robust competition, and will not in any way deal with pricing information," the GPhA emphasises, and also points out that the programme will require prior approval by both the FTC and the Department of Health and Human Services (DHHS).
The FTC Bureau staff's advisory opinion also notes that the ARI includes other features intended to minimise the risk that the programme would facilitate collusion among drugmakers or cause other harm to competition. These features include requiring binding commitments on ARI participants not to use the programme for anticompetitive ends.
In light of all these safeguards, the FTC staff say they have concluded that the ARI would be unlikely to harm competition, and they have not, therefore, any "present intention" to recommend an enforcement action to challenge it, "if it is implemented as described and the safeguards it contains are adhered to in practice."
GPhA, which had requested the FTC staff opinion on the ARI, welcomed its positive response as "a critical step forward" in addressing the shortages of needed medicines. "While this remains a complex issue that cannot be solved overnight, this type of private/public-sector, multi-stakeholder collaboration is exactly what is required to respond to this crisis," said Mr Neas.