The US House of Representatives has produced a “discussion draft” of a bill directed at the drug shortage problem that would require manufacturers to report to FDA anticipated shortages for specific categories of critically-necessary drugs and grant the agency authority to perform expedited reviews of major manufacturing changes.
The “Title IX” draft (link provided below) aims to amend the FD&C Act and cover drugs that are “life-supporting, life-sustaining, or intended for use in the prevention of a debilitating disease or condition.”
The first section contains a requirement to notify HHS six months prior to discontinuance of a drug or a manufacturing interruption that is likely to produce a drug shortage for the covered categories. It also requires HHS to publish definitions of “life-supporting,” “life-sustaining,” and “intended for use in the prevention of a debilitating disease or condition” within 18 months of enactment of the legislation.
Sec. 902 requires HHS to maintain an up-to-date list of drugs in short supply, including the reason for the shortage, and at its discretion to make the list publicly available.
The next section contains a provision allowing HHS to increase aggregate and individual quotas for controlled substances to alleviate shortages of those drugs.
The fourth and longest section of the bill addresses expedited review of major manufacturing changes being sought to prevent or alleviate a verified or anticipated shortage of a drug in scope of the regulation. It instructs FDA to perform the review within 60 days and requires that the firm have a plan to achieve full compliance with GMPs regarding the change along with sufficient resources and adequate controls in place until the plan can be fully implemented.
The last two sections require the Comptroller General of the US to conduct a study to examine the causes of drug shortages and make recommendations on how to prevent or alleviate them, and HHS to produce an annual report on drug shortages that describes the situation and FDA actions to alleviate it.
Congress began giving heightened attention to the drug shortage problem last fall.
The increasing number of shortages of medically-necessary drugs, and of generic injectables in particular, received attention at public hearings held by Congress and FDA in September (IPQ “The News in Depth” October 2, 2011).
In late December, FDA issued an Interim Final Rule (IFR) amending regulations relating to provisions of the Federal Food, Drug, and Cosmetic Act to require manufacturers who are the sole source of certain drug products to notify FDA at least six months before discontinuing product manufacturing (IPQ “Updates in Brief” January 11, 2012).
In early February, the issue of drug shortages along with a review of the final FDA proposals for the generic drug and biosimilar user fee acts (GDUFA/BsUFA) were the subject of a House Energy and Commerce Committee Subcommittee on Health hearing on February 9 (IPQ The News in Depth” Feb. 12, 2012).
In late February, FDA announced additional steps to increase the supply of critically needed cancer drugs to help prevent current and future drug shortages, including approval of a foreign substitute product and accelerated approval of a new domestic supplier. The agency also released a guidance clarifying agency expectations related to the mandatory and voluntary reporting of events that could result in shortages of prescription products (IPQ “The News in Depth Feb. 24, 2012).
Although the interim rule and FDA draft guidance apply only to sole source manufacturers, the new Title IX draft bill appears to expand the mandatory reporting requirement to include all manufacturers of the covered product categories.