On August 26th, in a Washington Times op-ed on the drug shortages, I wrote, “It is time not to fix the blame, but to fix the problem. Let’s start with the FDA.”
Today, Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Peggy Hamburg will join President Obama at the White House where he will sign an executive order instructing the FDA to take a series of actions to address the issue of drug shortages.
Thank you Mr. President.
The agency tries to do the best it can with limited authority, spare resources, and shared staff. In 2010, there were 178 drug shortages reported to the FDA. Is that a solid number? It’s hard to say, because current regulations do not require companies to notify FDA of shortages. The only requirement is that companies inform the agency six months in advance of discontinuing sole-source, medically necessary drugs.
President Obama will announce his support for House and Senate legislation that would require drug makers to notify the FDA six months ahead of a potential shortage, the official said. Under current regulations, drug manufactures are only required to notify the FDA if medically necessary drugs are being discontinued. Notification of shortages is strictly voluntary.
Thank you Mr. President.
When the drug shortage is for a generic product (as it often is), the FDA works with other firms making the drug to help them ramp up production if they are willing to do so. Often they need new production lines approved or need new raw material sources approved to help increase supplies. FDA can and does expedite review of these facilities to help resolve shortages of medically necessary drugs.
The FDA says major causes of drug shortages are quality or manufacturing problems, or delays in receiving components from suppliers. Drug makers also discontinue certain drugs in favor of newer medications that are more profitable. The FDA does not have authority to force drug makers to continue production of a drug.
The executive order instructs the FDA to speed reviews or alter production of drugs that face critical shortages.
Thank you Mr. President.
But what will surely get the most attention is the executive order’s instruction for the FDA to provide more information to the Justice Department about possible instances of collusion or price gouging.
Mr. Obama should say “thank you” to the Institute for Safe Medication Practices who had previously identified that, relative to drug shortages, the top three problems of fall squarely within the zone of appropriate FDA attention and action:
* Little or no information available about the duration of a drug shortage (85 percent).
* Lack of advanced warning from manufacturers or the FDA to alert practitioners of an impending drug shortage and suggested alternatives (84 percent).
* Little or no information about the cause of the drug shortage (83 percent).
But – the President isn’t giving the FDA any additional funding to bolster its efforts in surveillance or to expedite regulatory applications to address them.
Mr. President, show me the money.
My August op-ed concluded as follows:
“Should the issues of both authority and funding for the FDA's efforts to mitigate drug shortages be hung on the Prescription Drug User Fee Act Christmas tree … or addressed in separate legislation? Either way, it’s an issue that must be addressed with alacrity before it becomes a question of American lives.”
Thank you Mr. President for keeping the issue of funding on the front burner.
