Obama order aimed at prescription drug shortages, rising costs
The FDA will report more possible shortages, speed up regulatory reviews
The Justice Department will examine possible price gouging
Obama endorses more comprehensive legislation to deal with the problem
President Barack Obama signed an executive order Monday designed to help reduce a growing number of prescription drug shortages while protecting patients from possible pharmaceutical industry price gouging.
Among other things, the order requires the Food and Drug Administration to increase its reporting of possible shortages of certain prescription drugs, while also speeding up regulatory reviews of new drug manufacturing sites, drug suppliers and manufacturing changes.
The Justice Department will be tasked with examining whether specific drug shortages are tied to an intentional stockpiling of medications designed to raise prices.
Administration officials are also calling on Congress to pass more comprehensive legislation to boost the FDA’s power to address prescription drug shortages. The new steps are part of a highly publicized White House initiative to bolster the economy and help consumers without assistance from a sharply divided Congress.
“The shortage of prescription drugs drives up costs, leaves consumers vulnerable to price gouging and threatens our health and safety,” Obama said in a written statement. “This is a problem we can’t wait to fix.”
Obama administration officials have also sent a letter to drug manufacturers “reminding them of their responsibility to report the discontinuation of certain drugs to the FDA,” the statement noted. Drug manufacturers are being encouraged to voluntarily disclose possible prescription drug shortages in instances not currently required by law.
Under current law, pharmaceutical companies are only required to announce a decision to stop the manufacture of certain critical drugs if those drugs are available through a single manufacturer, according to the administration.
The White House is also directing the FDA to increase the total number of staffers dealing with drug shortage issues.
The new executive actions are being taken in response to a growing drug shortfall in the United States. The total number of prescription drug shortages almost tripled from 2005 to 2010, the White House noted.
As the number of shortages has grown, prices have skyrocketed in certain instances.
The White House cited an August Premier health care alliance report estimating that the “typical gray market vendor” jacks up prices by 650% on average.
“At the extreme,” the White House statement noted, “a drug used to treat high blood pressure that was normally priced at $25.90 was being sold at $1,200 due to a drug shortage.”
Later, White House Press Secretary Jay Carney told reporters the administration will continue to use its executive branch authority to act on a number of fronts without congressional assistance. Democrats have been frustrated by GOP opposition to the president’s $447 billion jobs plan, as well as a series of other administration-backed measures.
“One of the reasons why we can’t wait is because Congress won’t act,” Carney said. “As we have said throughout this initiative and in general, the president looks to ways he can use his executive authority to, broadly speaking, help Americans who can be helped through actions that this administration can take.”