The Obama administration on Monday asked drug companies to give more of a heads-up about drug shortages, pressing Congress to move legislation that would give the Food and Drug Administration more teeth to enforce early warnings and also doubling the small staff of an FDA office that deals with shortages.
President Obama signed an executive order asking FDA to work with the Department of Justice to make sure the shortages aren’t leading to price gouging.
“The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging, and threatens our health and safety,” Obama said in a statement. “This is a problem we can’t wait to fix. That’s why today I am directing my administration to take steps to protect consumers from drug shortages, and I’m committed to working with Congress and industry to keep tackling this problem going forward.”
Health and Human Services Secretary Kathleen Sebelius admitted that the order didn’t have much clout and urged Congress to hurry up with the legislation. “We don’t have a lot of teeth in terms of enforcement,” she told reporters on a conference call. “We were hoping that by this point, Congress would have acted.”
Joint bills to give FDA more clout to prevent drug shortages have been introduced: S. 296 sponsored by Sen. Amy Klobuchar, D-Minn., and H.R. 2245 by Rep. Diana DeGette, D-Colo. Both have bipartisan support and no real opposition.
The executive order directs FDA to broaden reporting of potential shortages of certain prescription drugs and to speed up work to prevent or respond to shortages. FDA Commissioner Dr. Peggy Hamburg said even a little more notice can help the agency ensure that hospitals and clinics that need the drugs the most get them.
Hamburg said the order would raise the number of FDA staff working directly on the issue from five to 11.
“While FDA successfully prevented 137 drug shortages between Jan. 1, 2010 and Sept. 26, 2011, prescription drug shortages continue to threaten the health and safety of the American people,” the White House said in a statement.
“These shortages could lead to price gouging, which has raised serious concerns. For example, the ranking member of the House Committee on Oversight and Government Reforms, when announcing his investigation into so-called gray markets, expressed concerns about a report that a leukemia drug whose typical contract price is about $12 per vial was being sold at $990 per vial – 80 times higher,” the White House statement said.
The order directs FDA to do more to get drug companies to give early notice when they are running out of a drug. “The Executive Order also requires FDA to expand its current efforts to expedite review of new manufacturing sites, drug suppliers, and manufacturing changes to help prevent shortages,” the White House said.
The White House and FDA say the number of reported annual drug shortages has nearly tripled, from 61 in 2005 to 178 in 2010. Most involved sterile injectable drugs, such as cancer chemotherapy.
"These can be life and death situations for families, and we need to act quickly to address this urgent public health crisis,” Klobuchar said in a statement.
"The leading reasons for the reported shortages were problems at the manufacturing facility (43 percent), delays in manufacturing or shipping (15 percent), and active pharmaceutical ingredient shortages (10 percent)," the White House said in a statement.
“Manufacturing quality problems that have resulted in shortages can be serious, including findings of glass shards, metal filings, and fungal or other contamination in products meant for injection into patients."
Raising the price the government pays for drugs won’t help, said HHS’s Sherry Glied, in part because the government doesn’t reimburse companies directly.
“We can’t fix the capacity issue,” Sebelius said. “The demand for a number of these drugs has risen dramatically.”
And Hamburg said stockpiling won’t work because it’s so hard to predict which drugs might be in demand, and because making a stockpile could create the very shortage it’s meant to prevent.
Advocates praised the move.
"The availability of cancer drugs can mean the difference between life and death for someone with cancer, and the drug shortage crisis is making it difficult or impossible for some cancer patients to get the medications they have been prescribed," said Christopher Hansen, president of the American Cancer Society Cancer Action Network