U.S. Begins to Address Drug Shortages

Last week’s executive order was the first one in more than 25 years directly affecting FDA operations. That in itself speaks to the gravity of the issue it addresses: shortages of drugs, many of them life-saving.

President Obama’s order had two clear messages:
1. Drug shortages are too critical to ignore.
2. Congress has been derelict in resolving them.

As reported on FDA Law Blog, the number of prescription drug shortages nearly tripled between 2005 and 2010. Among the missing medicines are treatments for child leukemia, breast cancer, colon cancer, anesthetics and antibiotics.

If there isn’t enough medicine to treat everyone who needs it, doctors have to ration. Only patients in the worst circumstances get drugs and others either do without or receive a decidedly second choice. If there even is one.

And when someone must switch medicines in the middle of a course of treatment, the potential for reduced effectiveness is high.

The situation affects not only patient health and survival, it feeds a vicious cycle. Drug shortages create higher prices. They also can delay clinical trials for new, experimental treatments if the “control” group (subjects who are testing the standard treatment in comparison to the new one) is assigned to receive the absent drug.

The causes of drug shortages are many. The FDA has identified “quality/manufacturing issues,” production delays and the discontinuation of older drugs that don’t bring as much profit to their manufacturers as they used to.

Free-marketers say prices of older drugs are low until supply runs low. Industry officials say even the higher prices those drugs would bring if more were manufactured aren’t enough to offset the cost of slicing through the government red tape to increase production.

Once again, Big Pharma’s lust for profit compromises human health.

Congress introduced legislation earlier this year to expand FDA authority to require advance notice of impending drug discontinuations and notice of any circumstances that might cause a drug to be discontinued or its production impeded. But the legislation is languishing in committee, so Obama said, essentially, “enough.”

The executive order directs the FDA to:

  • require sole-source drug manufacturers to notify the agency in advance of discontinuation that could lead to shortages of certain critical drugs;
  • expedite reviews of new drug suppliers, manufacturing facilities and manufacturing changes if such reviews would avoid or mitigate existing or potential shortages;
  • report drug stockpiling and price-gouging for scarce drugs to the U.S. Department of Justice.

These measures won’t necessarily resolve all the problems associated with drug shortages, but the order definitely has brought the problem to the fore and has figuratively kicked butt for legislative relief.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
Washingtonian Top Lawyer 2011
Avvo Rating 10.0 Superb Top Attorney Best Lawyers Firm
Contact Information