November 11, 2011—Four U.S. Senators yesterday called for a Senate hearing on possible legislative solutions to the growing problem of drug shortages.
The letter by Sens. Amy Klobuchar (D-Minn.), Bob Casey (D-Pa.), Richard Blumenthal (D-Conn.) and Jeff Merkley (D-Ore.) to the Senate Health, Education, Labor and Pensions (HELP) Committee comes on the heels of President Obama’s recent executive order on the subject.
“Shortages of critical prescription drugs have forced delays in treatment for patients across our nation who require these often lifesaving medications for the treatment of serious and chronic medical conditions, including cancer,” Klobuchar said. “A HELP Committee hearing would provide a timely opportunity to build on the work of the bipartisan drug shortages working group, and allow for experts from the [Food and Drug Administration], physicians, patients, and the pharmaceutical industry to explore legislative solutions.”
Klobuchar and Casey are the main sponsors of bipartisan Senate legislation (S. 296) that would require drug companies to notify the FDA of shortages. A similar measure (H.R. 2245) is also pending in the House.
The President’s Oct. 31 order partially addresses some of those bills’ goals. He directed the FDA to broaden its requirement for drug manufacturers to report production stoppages that could cause shortages and to speed up its review of new drug suppliers, manufacturing sites, and manufacturing changes that could prevent or alleviate shortages.
The President also ordered the FDA to inform the Department of Justice (DOJ) if it finds that market participants have responded to shortages by stockpiling affected drugs or selling them at dramatically inflated prices. DOJ will then determine if any laws have been broken and, if so, take appropriate enforcement actions.
On the same day the President issued his order, the FDA announced that it would take several immediate actions, including reminding manufacturers of their current reporting obligations, encouraging companies to voluntarily report other possible disruptions, and providing additional staffing resources to the agency’s efforts to prevent and mitigate shortages. The FDA also plans to take longer-term actions, such as persuading manufacturers to develop backup plans for manufacturing and sources of active pharmaceutical ingredients (APIs) and other essential components and encouraging wholesalers to publicize their distribution methodologies for drugs experiencing shortages.
Pending Legislation
The House and Senate bills would require manufacturers to notify the FDA of planned drug stoppages at least six months in advance and any other stoppages or interruptions at least six months prior, or as soon as practical. Manufacturers that fail to meet the reporting requirements would face civil monetary penalties. The bills would also direct the FDA to develop evidence-based criteria for identifying drugs vulnerable to shortages and publish information about such drugs on its Web site. The FDA also would be required to work with manufacturers to create continuity of operations plans for drugs that are vulnerable to shortages.
“As the number of potentially life-threatening drug shortages continues to grow, it’s time for Congress to come together and pass our critical legislation,” Rep. Diana DeGette (D-Colo.), the chief sponsor of the House measure together with Rep. Tom Rooney (R-Fla.), said in a statement commending the President for issuing his directive to the FDA.
Hospital groups also applauded the President and implored Congress to act swiftly.
“The executive order is a solid step in the right direction but there is more to do to address this issue,” said Rick Pollack of the American Hospital Association (AHA) in urging Congress to pass the drug shortage bills. “The FDA has been working hard to address drug shortages for some time, but needs more people and more funding to address the broad-based issues that cause drug shortages,” added Henri R. Manasse Jr. of the American Society of Health-System Pharmacists (ASHP).
Over 200 Shortages This Year
Health care providers and their patients are facing unprecedented drug shortages. According to the FDA, there have been over 200 so far this year, more than triple the number five years ago. Of the 178 FDA-recorded shortages in 2010, 74 percent involved sterile injectable drugs, including oncology drugs, anesthetics, and emergency room medications. Fifty-four percent of these shortages of injectables were due to product quality issues, the FDA said, while 21 percent were caused by production delays and capacity issues. Other causes included product discontinuations, raw material challenges, increased demand to due to another shortage, loss of a manufacturing site, and component problems.
Health care professionals who track shortages say they see no evidence that federal drug pricing programs are contributing to the current crisis. Most stakeholders also seem to agree that hoarding and price gouging are not root causes of shortages, but instead are responses that make an already bad situation worse.
An AHA survey of 820 hospitals earlier this year found that almost 100 percent reported at least one drug shortage in the prior six months and nearly half reported 21 or more. A second survey by ASHP and the University of Michigan Health System pegged the national cost of managing drug shortages at $211 million annually.
Manufacturers say the FDA needs to streamline its processes for approving alternative API suppliers, alternate manufacturing facilities, and manufacturers that want to produce an existing product. Companies argue that the processes are too slow, leaving some drugs with only one approved API supplier or manufacturing facility. Red tape, they add, delays new manufacturers from entering the market and deters others from even trying.
The FDA’s current authority to prevent and mitigate drug shortages is very limited. The agency cannot dictate a manufacturer’s production quantity. A manufacturer must notify the FDA only if it plans to discontinue making a drug for which it is the sole producer and the drug is “medically necessary.” However, there is no penalty for failing to report. The FDA considers a drug medically necessary if it is used to treat or prevent a serious disease or medical condition for which there is no other alternative drug available in adequate supply that is judged to be an adequate substitute.