In December, FDA published an interim final rule amending post-marketing reporting requirements for sole manufacturers of lifesaving drugs as part of its effort to address a recent surge in drug shortages. The interim rule becomes effective on January 18.
While existing regulations require that only permanent discontinuances be reported to FDA, in practice some manufacturers voluntarily notify FDA about temporary discontinuances.
In the past two years, such notifications have enabled FDA to prevent 233 drug shortages by expediting the review of new manufacturing sites, new suppliers or new specifications, according to the agency announcement. However, recent data from FDA’s drug shortages program indicate that the number of drug shortages tripled between 2005 and 2010.
A survey conducted by the American Hospital Association (AHA) in July, 2011 indicated that almost 100% of the 820 hospitals surveyed had experienced at least one drug shortage in the prior six months.
Another survey suggested that drug shortages often result in the need for physicians to prescribe alternative therapies that may be less effective and can increase the potential for medication errors and poor patient outcomes.
The problem of chronic shortages of injectable drugs and allegations of price gouging has drawn further attention of the US House of Representatives on the heels of late-September House and Senate hearings into the possible causes and solutions for the drug shortages (IPQ “In the News” October 2, 2011).
In Mid-October, the topic was broached in a story on “NBC Nightly News” in the context of investigations by Rep. Elijah Cummings (D-MD) in which he asserted that “some companies are making the situation worse in the name of profits.” The story cited a recent study claiming that the average markup for drugs in short supply was 650%, and that several prominent hospitals have reported price gouging (IPQ “Updates in Brief” October 17, 2011)
The December interim rule was enacted without the standard six-month notification period under a provision that allows this action if the agency can show “good cause.”
FDA has determined that “good cause” exists for this interim final rule and that “notice and comment procedures are contrary to the public interest given the serious and growing threat to public health due to drug shortages.”
In particular, the interim rule modifies the definition for “discontinuance” and clarifies the definition of “sole manufacturer.”
● Discontinuance is defined as “any interruption in manufacturing of a drug for sale in the US that could lead to a potential disruption in supply of a drug product, whether the interruption is intended to be temporary or permanent.”
● Sole manufacturer is defined as “an applicant that is the only entity currently manufacturing a drug product of a specific strength, dosage form, or route of administration for sale in the United States, whether the product is manufactured by the applicant or for the applicant under contract with one of more different entities.”