US President Barack Obama yesterday announced a number of measures aimed at tackling the problems of prescription drug shortages and price "gouging" of those in short supply.
Pres Obama has signed an Executive Order directing the Food and Drug Administration (FDA) to broaden reporting of potential shortages of certain prescription drugs and to further expedite regulatory reviews which can help prevent or respond to shortages. The Order also directs the FDA to work with the Department of Justice, which will be examining whether potential shortages have led to illegal price gouging or stockpiling of medicines.
"This is a problem we can't wait to fix," said the President, announcing the Executive Order yesterday. "The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety," he added.
While the FDA has previously only been able to direct drugmakers to disclose the discontinuation of a critical prescription drug when it is available through a single manufacturer, the Executive Order directs the agency to take additional steps to require drugmakers to provide adequate advance notice of manufacturing discontinuances or other actions that could lead to critical shortages.
The Order also requires the FDA to expand its current efforts to expedite review of new manufacturing sites, drug suppliers and production changes, in order to help prevent shortages.
Yesterday, the White House also:
- sent a letter to drugmakers reminding them of their responsibility to report the discontinuation of certain drugs to the FDA. The letter also "encourages" firms to voluntarily disclose to the agency any potential prescription drug shortages in cases where disclosure is not currently required by law;
- increased staffing resources for the FDA's Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers; and
- released a report from the Department of Health and Human Services (DHHS) that assesses the underlying factors that lead to drug shortages, and an FDA report on their role in monitoring, preventing and responding to these shortages.
"While the causes and many of the solutions are outside of the FDA's authority, including the need for additional manufacturing capacity in the private sector, the Administration will continue its ongoing work with manufacturers and other stakeholders to help address drug shortages," said a statement from the White House.
The President also yesterday announced his support for bipartisan legislation in the House and Senate - Senator Amy Klobuchar's Bill S 296 and Congresswoman Diana DeGette's HR 2245 - which would require all prescription drug shortages to be disclosed and give the FDA new authority to enforce these requirements. In the meantime, the agency will establish a voluntary notification process that will encourage manufacturers to disclose more potential shortages.
- A recent investigation by Democratic Representative Elijah Cummings, a member of the House Committee on Oversight and Government Reform, into "grey market" middlemen companies - which charge exorbitant price for prescription drugs in critically short supply – stated that a leukaemia drug whose typical contract price is about $12 per vial was reportedly being sold at $990 per vial, or 80 times higher.
Moreover, a Premier healthcare alliance report released in August estimated that the typical grey market vendor marks up prices by an average 650%. At the extreme, a product used to treat high blood pressure that was normally priced at $25.80 was being sold at $1,200, as a result of a drug shortage, it said.
