Congressman Larry Bucshon (IN-08) and Congressman John Carney (DE-AL) released the following comments after introducing H.R. 3839, the Drug Shortage Prevention Act of 2012.
Congressman Bucshon (IN-08) states:
“As a physician, drug shortages for patients who need specialized care is a critical issue that deals directly with the well-being of our citizens. It is vital that we are proactive when it comes to preventing shortages and ensuring access to treatments that save lives and improve health. I am proud to work across the aisle with my colleague from Delaware on an issue of national importance that will truly improve the quality of life for the American people.”
Congressman Carney (DE-AL) states:
“Since 2005, the number of drug shortages in the United States has quadrupled, and cancer patients have been disproportionately impacted by this troubling trend. We must ensure that Americans have access to the critical drugs they need to stay healthy and fight back against deadly diseases. The Drug Shortage Prevention Act brings more efficiency to the manufacturing and distribution processes and requires the FDA to take action to prevent drug shortage problems before they begin impacting patients.”
Background:
In 2005, there were 61 drug shortages; in 2010, that number was 178; and in 2011, there have been over 230 shortages. Sterile injectable drugs account for the majority of the shortage—with oncology drugs, anesthetics, and nutrition drugs being particularly hard hit. The causes of the drug shortage crisis are numerous and complex; therefore, multiple solutions may be necessary. The President issued an executive order on October 31, 2011 that doubles the staff at the Food and Drug Administration (FDA) dedicated to addressing drug shortages, directs the Justice Department to examine the issue of price gouging and drug hoarding, and calls for FDA to expedite the review of new manufacturing sites, drug suppliers, and changes to the manufacturing process of drugs in shortage. It also calls on FDA to use its existing authority to require drug manufacturers to notify FDA of discontinuances that could lead to shortages of drugs.
The Drug Shortage Prevention Act codifies and expands on many aspects of the order. The bill streamlines intra-agency communications at FD A and communications between FDA, manufacturers, distributors, providers, and patients. The bill mandates expedited review of drugs that are vulnerable to shortage in order to prevent shortages in the first place and it requires FDA to a use more refined regulatory process that addresses manufacturing problems without instigating drug shortages.
The Drug Shortage Prevention Act takes the following steps to solve the problems at the root of the drug shortage crisis:
Problem: According to an October 2011 report by FDA, manufacturing problems and shortages of active pharmaceutical ingredients (API) were the primary causes of over half of the drug shortages between 2010 and 2011. However, FDA is not currently required to identify or perform special monitoring on drugs that are vulnerable to shortage (those with few manufacturers or API sites). Thus, FDA is reactive, rather than proactive, in preventing drug shortages.
Solution: Requires FDA to work with stakeholders to develop a Critical Drug List, which will identify drugs that are vulnerable to shortage.
Problem: While FDA works closely with the manufacturer of a drug in shortage, distributors of the drug often do not learn of a shortage until their requested shipment does not arrive. If distributors were made aware of imminent drug shortages, they could take steps to reallocate supply to postpone and mitigate the effects of a shortage.
Solution: Requires FDA to notify distributors of an imminent critical drug shortage. Distributors will then be on the alert for secondary buyers who may be attempting to hoard drugs and sell them on the grey market. Distributors will be better positioned to keep the critical drug out of the hands of grey market participants. If a wholesale distributor is determined by the Attorney General to be participating in stockpiling, price gouging, or other unlawful activities related to the distribution of a critical drug, FDA must withhold notification to that distributor until the Attorney General determines that the distributor is no longer participating in such activities.
Problem: Some physicians do not learn about a drug shortage until they attempt to use the drug on the operating table. Clinical trials across the country are facing disruption because hospitals do not learn of a critical drug shortage until the shipment fails to arrive at the hospital pharmacy.
Solution: Requires FDA to develop a system to notify members of the public (doctors, patients, etc.) on an opt-in basis when a drug is added to the Critical Drug Shortage List.
Problem: While FDA currently offers expedited processes for inspecting or approving manufacturing sites for drugs that are in shortage, this expedited review does not extend to drugs that are vulnerable to shortage. If a drug has only two manufacturing sites, and one manufacturing site shuts down, even temporarily, a shortage can ensue. To prevent a shortage, FDA needs to lower the barriers for manufacturing drugs or APIs that are vulnerable to shortage.
Solution: Requires FDA to expedite the review of any application seeking approval of a critical drug (one that is vulnerable to shortage and on the critical drug list). Requires expedited review of any request by a manufacturer of a critical drug to approve a change to the manufacturing process or facilities of that drug or to approve an application for an alternate active pharmaceutical ingredient supplier.
Problem: As a result of an inspection, a manufacturing site may be forced to completely halt operations until the problem is resolved. A regulatory action taken against a drug vulnerable to shortage can precipitate a shortage.
Solution: Requires FDA to improve communications between the regulatory offices and drug shortage office within FDA. Requires FDA to communicate any new regulatory concern identified about a critical drug within 1 business day to the FDA drug shortage office. Requires FDA to communicate any new regulatory concern about a critical drug within 5 business days to the manufacturer of that critical drug.
Problem: The Drug Enforcement Agency (DEA) currently sets quotas for controlled substances production. Some drug shortages involve these controlled substances, but manufacturers who have already manufactured their quota of that substance for the year can’t continue producing the drug, despite the shortage. DEA currently has authority to raise quotas, but it has not done so consistently or in a timely manner during shortages.
Solution: Requires FDA to notify DEA of any critical drug on the critical drug shortage list and provide information to the Attorney General to allow for the determination of whether it is appropriate to increase one or more quotas under the Controlled Substances Act in order to address the shortage. If a drug on the critical drug shortage list contains or is a controlled substance subject to a quota, DEA must increase the quota, in consultation with FDA, to address the critical drug shortage.
Problem: The U.S. does not have a national contingency plan to cope with a drug shortage crisis like the one we are currently experiencing.
Solution: Requires the Secretary to conduct a feasibility study to determine the efficacy of and logistics associated with creating a national contingency plan in the event of a critical drug shortage, including the creation of a national stockpile of drugs or expanding an existing national stockpile to respond to potential critical drug shortages.
