President Obama on Oct. 31 issued an executive order calling on manufacturers to be more proactive in reporting pharmaceutical shortages to the Food and Drug Administration.
The order does not give the FDA any additional authority. Rather, "it will marshal all the resources and regulatory power we already have to make sure Americans don’t leave pharmacies empty handed," Kathleen Sebelius, Health and Human Services secretary, said during a press briefing.
The "announcement today enhances and amplifies efforts we are already undertaking at FDA to monitor and prevent and respond to drug shortages," FDA Commissioner Margaret Hamburg said during the briefing.
Currently, drug makers are required to notify the FDA of an impending shortage if they are a sole-source producer or if the drug is for a life-threatening condition or a life-sustaining treatment, Dr. Hamburg said. The executive order directs the agency to broaden reporting so that it covers more drugs and to further expedite review of new manufacturing sites, drug suppliers, and manufacturing changes.
According to the FDA, the number of reported drug shortages has tripled from 61 in 2005 to 178 last year. The agency issued a report Oct. 31 outlining the shortage issue and its response. Of 127 shortages that were reported in 2010-11, 80% were for sterile injectables, including oncology drugs, antibiotics, and electrolyte/nutrition drugs. The agency found that the main reasons for the reported shortages were problems at the manufacturing facility (43%), delays in manufacturing or shipping (15%), and active pharmaceutical ingredient shortages (10%).
Shortages continue to be a significant problem. More than 80% of respondents to a recent poll by the Oncology Report said that shortages were affecting their prescribing.
Some shortages have been caused when a manufacturer simply decided to exit the market. But a separate analysis by the Health and Human Services department found that profits were not a key reason for shortages, at least for oncology drugs, Sherry Glied, Ph.D., HHS assistant secretary for planning and evaluation, said during the briefing.
The main issue in oncology is that there’s a greater demand for generics than there is supply, Dr. Glied said.
Dr. Hamburg said that the executive order would help if it spurs manufacturers to notify the agency earlier of impending shortages. The agency prevented 38 shortages in 2010 and 99 so far this year, in part because the manufacturer and the FDA were more proactive, she said.
In a third of the shortages, the agency asked a company to increase production. In 28% of cases, the FDA worked with manufacturers to identify ways of mitigating quality issues by being more flexible, and review of regulatory submissions was expedited in 26% of cases.
In addition to the executive order, the administration took several other steps to address shortages. The FDA sent a letter to drug makers reminding them of their legal responsibility to report the discontinuation of certain drugs and urged more voluntary reporting.
The White House also said that it would give the Department of Justice more authority to investigate potentially exploitative pricing of products in short supply.
The FDA will also double the size of its Drug Shortages Program, from 5 to 11 people, Dr. Hamburg said. She noted that the agency also uses staffers from other divisions to help address shortages.
The White House endorsed legislation that would give the FDA even greater monitoring and enforcement activity. The Preserving Access to Life-Saving Medications Act (S. 296) was introduced in February by Sens. Amy Klobuchar (D-Wisc.) and Bob Casey (R-Pa.).
At press time, the bill had 17 Senate cosponsors. Its House companion, H.R. 2245, was introduced in June by Reps. Tom Rooney (R-Fla.) and Diana DeGette (D-Colo.); that bill has 46 cosponsors.
In a statement, Rep. Rooney said, "I’m very pleased that President Obama is addressing this critical issue and supporting our bipartisan bill. The earlier doctors, suppliers, and the FDA are able to communicate a potential drug shortage, the better equipped they will be to respond and prevent a disruption in supply from occurring."
Rep. DeGette said, "Today’s announcement does not diminish the necessity of passing our bipartisan legislation. Not only does our bill go beyond what the president outlined today, but it will encase in law a common-sense approach to dealing with drugs that are heading toward shortage."