The number of drug shortages in the United States has grown substantially since 2006 and hit an all-time high in 2011, posing a risk to patients who rely on live-saving drugs for medical procedures and treatment.
That’s according to a new report released Dec. 15 by the U.S. Government Accountability Office, an independent investigative arm of Congress.
Since 2006, drug shortages – especially generic injectable drugs – have dramatically increased. In total, 1,190 shortages were reported from Jan. 1, 2001, through June 20, 2011, according to the GAO report. From 2006 through 2010, the number of drug shortages increased each year and grew by more than 200 percent over that period. A record number of 196 shortages were reported in 2010.
2011 has already outpaced 2010’s record – with 220 shortages reported this year, according to the Federal Drug Administration, and that number doesn’t include shortages the agency has helped prevent.
The findings of the GAO report were presented at a U.S. Senate Health, Education, Labor and Pensions Committee hearing on Dec. 15.
“For patients, drug shortages can literally be a matter of life or death,” Sen. Thomas Harkin, D-Iowa, said at Thursday’s hearing. Harkin is the chairman of the Health, Education, Labor and Pensions Committee.
According to a November report by the IMS Institute for Healthcare Informatics, 16 percent of drug shortages are oncology drugs, followed by anti-infectives at 15 percent and cardiovascular drugs at 12 percent. Pain drugs make up 9 percent of drug shortages and vitamins and minerals account for another 9 percent. About 28 percent of drug shortages are other medications.
When a drug is not available to a patient, healthcare providers must use an alternative drug, which is sometimes less effective, or wait until that drug becomes available, potentially delaying much-needed treatment.
“The shortages are creating a public health menace,” Sen. Richard Blumenthal, D-Conn., said at the hearing. “These drugs are needed, and stronger governmental action seems to be absolutely necessary.”
In response to the crisis, President Barack Obama issued an interim final rule on Dec. 15 intended to help prevent drug shortages. The rule builds on an executive order Obama issued in October and will require manufacturers that are the sole producer of certain critical drugs to immediately report any interruptions in manufacturing of products to the FDA.
But some healthcare experts and lawmakers, like Blumenthal, say that the new rule isn’t enough.
Currently, the FDA is constrained in its ability to protect the public from drug shortages. For example, the FDA cannot require manufacturers to provide the agency and the public with information about shortages, or require that manufacturers take certain actions to prevent, alleviate or resolve shortages.
Sen. Jeffrey Merkley, D-Ore., said he supports giving the FDA more power to regulate drug shortages.
Sen. Sheldon Whitehouse, D-R.I., said he would be in favor of establishing a national drug distribution system that would provide hospitals and other healthcare providers with information of where drugs are and if certain drugs are experiencing a shortage.
Ralph Neas, CEO of the Washington, D.C.-based Generic Pharmaceutical Association, added to that sentiment, proposing a so-called Accelerated Recovery Initiative at the hearing. The initiative would establish a consolidated supply schedule for various stakeholders across the country.
The complex problem of drug shortages is due to several compounded factors, including poor business incentives, manufacturing issues, difficulty obtaining raw materials to make certain drugs and consolidation of the drug market.
Throughout the recession, consolidation especially has been a problem, as smaller and less profitable drug companies and manufacturers merged with or were bought by larger, more lucrative ones.
“Shortages are not a feature of the U.S. economy in general,” said Sherry Glied, assistant secretary for planning and evaluation at the U.S. Department of Health and Human Services.
Glied explained in her testimony to the Senate committee that the problem of drug shortages is not price. On the demand side, treatment patterns don’t change much, so there is a somewhat steady need for certain drugs. But on the supply end, manufacturing is slow because companies must first get approval by the FDA to make a certain drug, and after that, it may take several years just to produce the correct manufacturing equipment to start making a drug, Glied explained.
The drug shortages reviewed in detail in the GAO report were generally caused by manufacturing problems and exacerbated by multiple difficulties. Twelve of the 15 drug shortages reviewed were primarily caused by manufacturing problems, including those that resulted in manufacturing shutdowns, according to information provided by the FDA and by manufacturers.
Dr. Sandra Kweder, deputy director at the FDA’s Office of New Drugs, said the agency has a longstanding backlog of generic drug applications that could help alleviate drug shortages.
But the time to get FDA approval to manufacture these drugs varies depending on the applicant and where the proposed facility will be.
Kweder said at the committee hearing that the FDA tries to expedite the process for generic drugs in short supply – especially those that could pose a public health risk – and can approve those applicants in several weeks to months. Kweder said the FDA has also recently doubled its staff working in its drug shortages unit.
So far, lawmakers and healthcare experts are unsure where the Obama administration’s latest measure will help alleviate drug shortages. Glied said she believes current shortages will only be resolved when long-term manufacturing issues are addressed.