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The FDA and Public Notices of Drug Recalls – Is It Enough?

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In a recent Huffington Post article, When Your Medicine Makes You Sick,   lawyer Spencer Aronfeld takes a look at the FDA procedure for drug recalls. He seems to think the process of managing the complex approval and monitoring system of drugs could be simplified.

As Aronfeld notes, Americans consume over $300 billion dollars worth of pharmaceutical drugs a year. He suggests that it should be mandated that the pharmaceutical industry contact consumers via mail or email directly, or via the pharmacy, Medicare or Medicaid.   This is an idea that should be considered.  It is doable, but skeptics could point hurdles such as, with that many drugs coming through hospitals, clinics, doctors’ offices and a variety of pharmacies, physical and mail-in, it would require a very effective ground game, and perhaps high costs (the drug industry would point out, which would be “passed on” to consumers) to achieve desired results.

Under the current FDA system, the FDA releases a report every Wednesday, listing the drugs that are labeled, “Human drug product recalls pending classification”. This is a sort of warning before the event. The problem arises when a serious issue is detected on, say, a Thursday. We have to wait 6 more days to learn we are at risk of a serious issue—assuming we are even reading this list or worrying about drug safety in the first place.

Whose responsibility is it to notify consumers about a drug recall? Once the FDA issues its notice, which only applies to Class I recalls, anyone can go to the FDA website and read the notice.  Do we expect our doctor to read the alert, search the database for every patient she has prescribed the drug for, find their email address, and send them a warning? Or make phone calls to all those people who don’t use email? And, what about the pharmacy, should it do the same thing?

The notification problem is complex. Our healthcare system is complex. Answering this question will require expertise and considered thought and debate.  The best way to start solving the problems is by increasing awareness.  The FDA has, arguably, started this process.  Once we begin to understand the problem we can take steps to enhance our knowledge and our safety.

One of the first things you can do is to understand how the FDA operates and know what the levels of recalls indicate. A Class I recall is the most severe, “which means there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” ( FDA Recall Classifications ) This level of recall requires immediate action, whereas the Class III indicates an issue but not one that is likely to cause “adverse health conditions.”

There are limits to the power and the capacity of the FDA. They are limited to a degree by their official mandate:

  • Protecting the public health by assuring that foods (except for meat from livestock, poultry and some egg products which are regulated by the U.S. Department of Agriculture) are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective

 

  • Protecting the public from electronic product radiation

 

  • Assuring cosmetics and dietary supplements are safe and properly labeled

 

  • Regulating tobacco products

 

  • Advancing the public health by helping to speed product innovations

Pending legislation would give the FDA more authority over compounding pharmacies but doesn’t address other prescription drugs or the notification process for recalls.  We can argue that the FDA is not working hard enough or fast enough to address problems in the pharmaceutical manufacturing industry. Public watchdog agencies push for more press releases. But there has to be a reasonable balance of public notification and operational efficiency, especially given federal budget constraints.  Regardless, the ultimate burden of notification should be with the manufacturer, because it made, marketed and distributed the product, and it has the resources to notify those potentially harmed. 

For now the best you can do is attempt to monitor your medications. Visit the FDA Safety page  to see the latest recalls, market withdrawals and safety alerts. Each item is listed by brand name with a product description, the problem, company and a photo or detail about each recalled item. 

1 Comment

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  1. lucas sommer says:
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    My family has been affected by drug recalls. Thank you for finding the article from Aronfeld and sharing it here.