Drug shortages in the US are a growing crisis, members of Congress were told last Friday, September 23. And there is no single reason why this is happening and no easy solutions to the problem.
Problems lie mostly in older generic versions of sterile injectable drugs, which are low-priced and
- complicated to manufacture
- made by a only a few companies
- manufactured in aging plants where quality is hard to maintain.
Dr. Howard Koh, Assistant Secretary of Health in the Department of Health and Human Services, told the House Energy and Commerce Subcommittee on Health that the number of drugs in shortage had grown from 61 in 2005 to 178 in 2010 and is even larger in 2011. Over 90 percent of drugs in shortage are medically necessary — drugs that are used to prevent or treat a serious disease for which there is no alternative. Some are made by only one company.
According to Dr. Koh, cancer drugs made up about a third of the shortage (28%), followed by antibiotics at 13%.
In 2010 and 2011, Dr. Koh said that
- More than half of shortages (about 54 percent) were due to quality problems including drugs contaminated with tiny particles, inpurities, bacteria, or crystals.
- About 21 percent happened when there were production delays at manufacturing facilities or plants lacked the capacity to meet demand.
- Another 11 percent were caused when manufacturers stopped production, usually for business reasons.
- Problems getting raw materials, lack of components, and loss of a manufacturing site also were at the bottom of some shortages — but fewer than 10 percent.
- Finally, an increase in demand due to another manufacturer’s difficulties let the shortage spread.
Several subcommittee members asked why rules of supply and demand didn’t solve the problem, leading to higher prices and increased production to meet demand. Koh explained that the vast majority of drug prices are set in contracts and cannot respond to short-term shortages. In addition, pharmacy benefit managers and other drug purchasers are buying in such large quantities that they put pressure on prices. Finally, when shortages occur, manufacturers may not have necessary capital to expand production.
While it might seem a simple solution to allow importation of drugs that are in shortage, the FDA needs to be sure that imported drugs are safe and effective and manufactured in a facility that meets FDA standards. Koh reported that the FDA has done this for a number of critical drugs in shortage including Xeloda, leucovorin and levoleucovorin.
Although FDA currently has no authority to require manufacturers to notify them if they anticipate problems in manufacturing a drug or stopping making it, voluntary reporting enabled the FDA, in collaboration with manufacturers, to avert 38 shortages in 2010 and 99 shortages this year. Strategies available to FDA include:
- Approving importation of drugs from FDA-approved foreign sources as they did with TEVA for leucovorin.
- Speeding the process of approving another manufacturer for the drug from an average of two years or more to three or four months.
- Expediting the review and reopening of a manufacturing plant or production line closed because it didn’t meet FDA Good Manufacturing Practices inspection.
All of these require that FDA get as early notification of potential disruptions as possible. To that end, Rep. Diana L. DeGette (D-Colo.) reminded the subcommittee that the Preserving Access to Life-Saving Medications Act (H.R. 2245) would require manufacturers to notify the FDA if they are planning to discontinue a drug at least six months in advance. For other potential disruptions in manufacturing, the FDA must be notified as soon as the problem is known. There are penalties for not complying.
In addition, the legislation sponsored in the House by DeGette and Thomas J. Rooney (R-Fla.) would require the FDA to publish information relating to manufacturing problems and drugs in actual shortage on its website. A companion bill in the Senate (S. 296) has been introduced by Senator Amy Amy Klobuchar (D-MN) and Robert Casey (D-PA).
The gray market that offers drugs in shortage to desperate pharmacists and health care facilities was condemned by several witnesses and subcommittee members. With markups that average 650 percent and go as high as 4500 percent, gray marketeers usually can’t tell pharmacist buyers where the drug came from, whether it has been safely stored, or whether it is counterfeit.
Among solutions to the crisis offered during the hearing were:
- An early warning system for potential shortages with teeth — such as that offered by the DeGette-Rooney legislation.
- Generic drug manufacturer user fees to strengthen FDA resources to manage drug supply.
- An increase in FDA resources directed at drug supply and drug shortages.
- Incentives for manufacturers to enter the market for generic sterile injectable drugs or to update manufacturing facilities.
- Improved funding for the FDA and its resources.
- Better communication between FDA field inspectors and drug shortage programs so that potential manufacturing shut-downs due to lack of Good Manufacturing Practices can be known early.
- Most of all, good collaboration and communication among manufacturers, the FDA, pharmaceutical distributors, pharmacists and healthcare facilities that buy drugs in shortage, and the doctors and nurses who prescribe and administer them.
Rep. Frank Pallone, Jr. (D-NJ) asked that a statement from Fight Colorectal Cancer be entered in the record.
Want to Help
As Rep. DeGette said, the Preserving Access to Life-Saving Drugs isn’t the whole answer to the drug shortage, but it is a necessary first step.
In November, Fight Colorectal Cancer is sponsoring a webinar to help you learn what to do when your doctor is out of a drug that you need.
- What to Do When Your Doc is Out of 5-FU (or Leucovorin…or Irinotecan)
- November 16, 2011
- 8:00 to 9:30 p.m. EST