Thursday, February 27, 2014

FDA's plan to ease drug shortages needs work

According to a just-released analysis by the Government Accountability Office, the Food and Drug Administration is doing a better job at preventing drug shortages.

As Center for Drug Evaluation and Research Deputy Director Doug Throckmorton recently told Congress, new shortages declined in 2012 for the first time in a number of years and 2013 data indicated a similar downward trend. He said the agency's new authorities (granted under a 2012 law) have allowed the FDA to manage shortages more aggressively.

In 2010, 178 drug shortages were reported to the FDA. Thirty-eight shortages were prevented by companies voluntarily notifying the agency of potential issues that could lead to shortages; the agency was able to work with the companies to avoid shortages.

Inside CDER resides the agency’s Drug Shortage Program. The program was established to address potential or actual shortages of drugs that have a significant impact on public health. Through communication, facilitation and negotiation, the program works with pharmaceutical manufacturers and components of FDA to manage product shortages.

For example, when the drug shortage involves a generic product, 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 or raw-material sources approved to help increase supplies. The FDA can and does expedite review to help resolve shortages of medically necessary drugs.

But the FDA can’t require the other firms to increase or commence production.

The agency tries to do the best it can with limited authority, spare resources and shared staff. In addition to direct communication with industry, the Drug Shortage Program also gets reports from health care professionals, patients and professional organizations using the email address">

But, as you can imagine, there is not a lot of email traffic. And there is no social media effort to promote the program’s purpose or existence.

The FDA’s Drug Shortage Program is a good start, but it’s not getting the job done. The problem is getting worse. The agency needs more authority and greater resources. In short, more needs to happen.

The Institute for Safe Medication Practices reports that in a survey of 1,800 health care practitioners, more than half said they frequently or always encounter difficulties associated with drug shortages.
The top three problems 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).

Survey respondents felt “unsupported by the FDA and are perplexed regarding why the U.S. is experiencing drug shortages of epic proportion that are often associated with third-world countries.”
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, which authorizes the agency to collect fees from companies that produce certain drug or biological products, 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.

In addition to new actions, the FDA has been more willing to demonstrate regulatory flexibility.
For example, in some cases where particles were found to be contaminating a drug that was in short supply, the agency allowed the company to filter the drug to avoid disrupting supplies instead of shutting down the production line altogether.

While the FDA’s new authorities are both timely and important, there are many pieces to the drug shortages problem – not the least of which is that 30 percent of manufacturing capacity of hospital injectables is off-line due to FDA inspection issues.

That’s a lot of capacity. In fact, according to the agency, 43 percent of reported potential shortages were due to manufacturing problems. Safety is non-negotiable and alleviating a shortage by shorting good manufacturing practices is a bad and dangerous pathway. Expediency causes as many problems as it solves.

That being said, regulatory discretion must be part of the solution – and per Throckmorton, it is. With 30 percent of production capacity off-line because of FDA issues, the agency must continue to work with manufacturers to find creative, science-based solutions. If you create a "science- and risk-based action plan," industry can often address quality issues without disrupting supplies of essential drugs.
But who inspects the inspectors? Perhaps the FDA should undertake an agency audit to see why there’s been such a jump in manufacturing issues. It’s hard to believe that year-over-year, production quality control has suffered such a significant lapse. Is there something wrong in the way FDA inspectors (many of them still wet behind the ears and eager to please) are doing their jobs? It’s a question worth asking – and answering.

But the real headline is that artificially low prices are the major cause of drug shortages.
Most of the drug shortages that occur in the U.S. arise in the generics market, where profitability is fairly low. For many of these drugs the market can only sustain a handful of manufacturers -- sometimes just one or two. So, when supply disruptions occur -- caused by manufacturing violations, production delays, shipping problems or ingredient issues -- there aren't a lot (or in many cases any) additional producers in the market to pick up the slack.

In plain English: Artificially low prices caused the manufacturing decline of the drugs that are in short supply, and a variety of perverse government regulations (ranging from Medicaid reimbursement rates to the benighted 340B Drug Pricing Program) contribute to the causes.
Where there is still a profit left, you rarely see shortages.

Congrats to the FDA for a job well begun. But the issue of drug shortages -- and particularly the economic issues that must be addressed -- must not be left half done.

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