May 7, 2012
By Reps. John Carney (D-DE) and Larry Bucshon (R-IN)
Across the country, a drug shortage crisis is endangering the lives of millions of Americans. In the past seven years, drug shortages have risen by almost 400 percent. In 2005, there were 61 drugs in critical shortage. Last year, that number climbed to 230.
There is no magic bullet to solve the problem of drug shortages. The crisis is the result of compounding factors that range from manufacturing problems to reimbursement rates to price gouging. Earlier this year, we introduced legislation to address the issue of manufacturing, and our bill, H.R. 3839, the Drug Shortage Prevention Act, makes simple, fundamental changes to the manufacturing process to ensure that more drugs enter the market more quickly.
Cancer drugs, anesthesia drugs and nutrition medicines are overwhelmingly affected by these shortages. Most of these drugs are delivered intravenously, as opposed to in pill form, and the manufacturing process is complex, time-consuming and highly precise. Many of these drugs have only one or two manufacturers in the market, so when a manufacturing problem occurs, it can quickly cause a shortage.
The Drug Shortage Prevention Act requires the Food and Drug Administration to work with stakeholders to develop a list of critical drugs that are vulnerable to shortage to ensure that doctors, distributors and patients have access to the information they need to effectively plan and determine appropriate action. More importantly, the FDA will be required to expedite the review of drugs on the shortage list in order to prevent shortages in the first place.
Expediting FDA review is important in two ways. First, it serves as an incentive for manufacturers to begin producing these critical drugs because their application will move to the front of the line, ahead of applications for drugs with abundant supply and significant manufacturing capacity. Secondly, if a current manufacturer of a critical drug can identify changes to its manufacturing process that would prevent or mitigate a shortage, the FDA would be required to quickly review those changes so companies can put them into practice and avoid a shortage.
Both of these requirements are key to shoring up manufacturing capacity in order to prevent a shortage.
Finally, our legislation requires the FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages. In other words, if there is a problem on a specific manufacturing line at a plant with multiple manufacturing suites, the FDA should address the single problematic line rather than interrupting all manufacturing at the plant.
Our bill also streamlines communication among the FDA, manufacturers, distributors, providers and patients. We want to empower physicians to make smarter diagnostic decisions in the face of shortages and give patients the information they need to be their own advocates if a medication they rely on goes into shortage. Our bill also enables distributors to better monitor secondary buyers who may be attempting to hoard drugs and sell them on the grey market, a practice that is leading to drastic price increases for drugs in shortage.
Since the introduction of the Drug Shortage Prevention Act in January, our legislation has earned bipartisan support in Congress, and many of our colleagues have shown a willingness to put their heads together and come up with other important solutions. Our legislation has also earned the support of the American Society of Clinical Oncology, the American Society for Parenteral and Enteral Nutrition, the Hematology/Oncology Pharmacy Association and the American Hospital Association.
This is not a partisan issue and there is nothing partisan about our legislation, which is designed to get at the heart of some of the problems leading to drug shortages.
In the coming weeks, as Congress considers the Prescription Drug User Fee Authorization Act, we urge our colleagues to include the Drug Shortage Prevention Act in the comprehensive reauthorization package.
Congressional gridlock on other issues shouldn’t get in the way of lifesaving legislation to address problems such as drug shortages. We are working hard to ensure that it does not.
Rep. John Carney is a Delaware Democrat. Rep. Larry Bucshon is an Indiana Republican.