Information please
One response is for manufacturers to inform FDA in advance of supply problems. The agency reports that early warnings helped
it head off 38 potential shortages in 2010 and 99 so far this year. When FDA knows of a looming supply interruption, its staff
can expedite the review and approval of supplements for new suppliers, alternative production sites and changes in specifications—actions
responsible for most (84) shortage preventions this year. Sometimes, FDA can bend the rules to permit continued marketing
of a violative product with some corrective action. And the agency has had some success in encouraging other firms to ramp
up production or to enter a market through speedy regulatory actions.
FDA also has approved temporary importation of unapproved sources to fill supply gaps, a strategy that helped alleviate shortages
this year in several cancer drugs. APP Pharmaceuticals worked with FDA to reduce a shortage of the widely used anesthetic
propofol by importing the product from Germany.
Unfortunately, FDA often lacks information on looming shortages because, under current law, only sole-source manufacturers
of critical medicines have to notify FDA of plans to discontinue production. Some companies voluntarily inform FDA of problems
likely to lead to short supplies, but most do not, and often the information comes in too late for timely resolution.
To remedy this limitation, Congress is looking to enact legislation that would require six-months advance notification of
production changes for a broad range of prescription drugs. Rep. Diana DeGette (D-CO) has bipartisan support for legislation
in the House, and Sens. Amy Klobuchar (D-MN), and Robert Casey (D-PA) lead the early-notification campaign in the Senate.
They propose leeway for manufacturers who show that a manufacturing problem could not be anticipated, as well as penalties
for failure to comply. A related proposal requires manufacturers to inform FDA of situations that make a product vulnerable
to shortages, such as a single API source, to highlight the need for back-up emergency sources.
Although advance notification may help FDA head off some shortages, the danger is that wider release of such information could
lead to hoarding and price gouging. Gray-market profiteers are inundating health professionals with faxes and phone calls
offering scarce drugs at huge markups. Rep. Elijah Cummings of Maryland, top Democrat on the House Oversight and Government
Reform Committee, launched an investigation of secondary distributors last month, seeking information on sources and profits
for certain drugs. His targets include high-priced offers of leukemia treatment cytarabine by Allied Medical Supply (Florida);
Superior Medical Supply (Colorado) offers for paclitaxel; Premium Health Services (Maryland) sales of leucovorin; fluorouracil
offers from PRN Pharmaceuticals (Maryland); and Reliance Wholesale (Florida) marketing of magnesium sulfate.
To avoid profiteering, FDA wants to be informed by manufacturers of possible shortage situations, but doesn't necessarily
want to make that information public right away, noted Sandra Kweder, deputy director of CDER's Office of New Drugs at the
House hearing. The agency first wants to assess if the problem is real, its likely impact, and what actions can be taken to
mitigate difficulties. "Early notification to FDA is a very useful tool," said Kweder, "but it's different from early publication."
Advance notification is not always possible. FDA officials concede that many manufacturing problems cannot be anticipated,
such as equipment breakdowns and plant fires. In addition, earthquakes, volcanoes, and other natural disasters can suddenly
disrupt supplies and material transport.
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