From the U.S. Government Accountability Office, www.gao.gov Transcript for: Prescription Drug Shortages and FDA's Response Audio interview by GAO staff with Marcia Crosse, Director, Health Care Related GAO Work: GAO-12-116: Drug Shortages: FDA's Ability to Respond Should Be Strengthened Released on: December 15, 2011 [ Background Music ] [ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and information from the Government Accountability Office. It's December 15, 2011. Nationwide shortages of prescription drugs have increased in recent years. The Food and Drug Administration established a drug shortage program to help prevent, alleviate, and resolve these shortages. A group led by Marcia Crosse, a director in GAO's Health Care team, recently reviewed the causes of drug shortages and FDA's response. GAO's Jeremy Cluchey sat down with Marcia to learn more. [ Jeremy Cluchey: ] Shortages of prescription drugs seem to have been making the news more often in recent years. What did you find are the current trends around these shortages? [ Marcia Crosse: ] Well the news stories are correct. The shortages have been increasing steadily, more than tripled in a 5-year period and continues to increase. In particular, there are certain categories of drugs that are in short supply. About two- thirds of the drug shortages are for injectable drugs, so not the kind of things that most people pick up at their drug store, but things that are used in doctor's offices or in hospitals and there are three categories of drugs in particular that have been in short supply. Anesthesia drugs that are used to treat pain or in surgery, anti-infective drugs like antibiotics that are used to treat serious infections, and oncology drugs used to treat cancer patients. [ Jeremy Cluchey: ] Your team also looked at the causes for these shortages. What did you find there? [ Marcia Crosse: ] Well, when we look more closely, most of the problems are traceable to some kind of a manufacturing problem, a quality control issue a in a facility, and to a lesser extent, some supply problems for ingredients that go into drugs. And this is especially a problem for injectables because they're very challenging to produce. There are a lot of special controls for these kinds of drugs in manufacturing and the drugs have to be sterile. [ Jeremy Cluchey: ] Can you talk a little bit about some of the steps that FDA has taken in response to these shortages? [ Marcia Crosse: ] FDA's taken a variety of steps to try to assist manufacturers. They've assisted in resolving some of these quality problems on production lines. They've notified other manufacturers of the same products so that they can begin increasing the production of their drugs to fill the gap. They've allowed, on occasion, for a foreign version of a drug to be imported into the United States, which normally wouldn't be coming in across the borders. And they've assisted manufacturers with their suppliers either in identifying suppliers or in expediting the import of ingredients for drugs. They've, when they've been informed in advance, they can sometimes avoid a shortage from occurring, they can notify other manufacturers further in advance or they can take a variety of other steps. But manufacturers don't have to tell FDA if they're having a problem or if they're planning to shut down their production line for some reason. So this makes it a little more complicated for FDA. [ Jeremy Cluchey: ] And to what extent did you find that FDA's response has been successful so far? [ Marcia Crosse: ] Well FDA has been able to head off some shortages from occurring. We estimated that in the first half of 2011 they had avoided about 50 drug shortages from occurring, but we think there's some other steps that should be taken. We think congress should consider giving FDA authority to require manufacturers to provide them with notice in advance when they know there's gonna be a shutdown of a production line. We think this would assist FDA in being able to take actions to avoid shortages from occurring in the first place, or at least to reduce their impact. We also think FDA needs to take some steps on its own to improve its management of these shortages. For one thing, we think they need better information systems in place so that all parts of the organization can be aware of the shortages and can take steps in their own areas of control to try to reduce the impact. We also think they could better track what goes on and look for patterns of problems if they had better information. And then the other thing that we think they need to do is assess the resources they've been devoting to this. They have quite recently added a couple of additional staff to assist with this program, but over the prior period when drug shortages were steadily increasing, they weren't increasing the number of staff assigned to work on this, so the workload was really too heavy for the individuals they had assigned. [ Background Music ] [ Narrator: ] To learn more, visit GAO's website at gao.gov and be sure to tune in to the next edition of GAO's Watchdog Report for more from the congressional watchdog, the Government Accountability Office.