A Dangerous Gap in FDA Recall Authority

You may be surprised to learn that the Food and Drug Administration (FDA) lacks the legal authority to require a pharmaceutical company to recall a drug product because of potential contamination or other serious safety problems. In fact, the FDA has mandatory recall authority for only five categories of products: infant formula, food, medical devices, biologic products (for example, blood products) and tobacco products.[1],[2]

Historically, the lack of mandatory drug recall authority has apparently not posed a significant threat to public health because mainstream drug manufacturers have routinely recalled products when asked to do so by the FDA. These companies recognized that they would be exposed to significant liability risks and bad publicity if they disregarded such a request from the agency.

However, a couple of recent troubling incidents indicate that the FDA’s lack of mandatory drug recall authority poses substantial risks to patients. The first incident involved Unique Pharmaceuticals, a drug compounding company in Temple, Texas, that nationally distributes drug products marketed as sterile. On July 11, the FDA alerted health care professionals not to use those products because of concerns that they may not be sterile, putting patients at risk of serious harm.[3] The agency had asked the company on July 10 to recall its products, but the company refused.[4] Unique Pharmaceuticals finally announced a voluntary recall of all its sterile drug products on July 19.[5]

The second incident involved Downing Labs (also known as NuVision), a compounding pharmacy in Dallas that also nationally distributes drug products marketed as sterile.[6] On July 18, the FDA alerted health care professionals not to use sterile drugs made by this company because of concerns that the products could be contaminated and could result in serious and potentially life-threatening infections.[7] The agency had issued similar alerts about this same company’s products on May 18 and Aug. 16, 2013, but the company repeatedly refused to recall its purportedly sterile drugs.[8] Given the severity of the most recent safety concerns, the FDA should again ask Downing Labs to immediately recall its products, but no such recall had been announced when Worst Pills, Best Pills News went to press.

When the FDA identifies drug product problems that pose risks of serious harm to patients, the companies involved must take swift action to remove the potentially dangerous products from the market. If drug companies balk at recalling drugs when asked to do so, then the FDA must have legal authority to compel such action. To better protect public health, Congress must pass a law granting the agency that authority.

References

[1] Burrow VK. The FDA’s authority to recall products. Congressional Research Service Report for Congress. August 4, 2010. http://nationalaglawcenter.org/wp-content/uploads/assets/crs/RL34167.pdf. Accessed July 22, 2014.

[2] Food and Drug Administration. Annual report to Congress on the use of mandatory recall authority – 2013. http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm382490.htm. Accessed July 22, 2014.

[3] Food and Drug Administration. FDA alerts health care professionals not to use sterile drugs from Unique Pharmaceuticals. July 11, 2014. http://www.fda.gov/Drugs/DrugSafety/ucm404758.htm. Accessed July 22, 2014.

[4] Ibid.

[5] Food and Drug Administration. Recall -- Firm press release: Unique Pharmaceuticals, Ltd. Announces a voluntary nationwide recall of all sterile compounded preparations within their expiry period due to a lack of sterility assurance. http://www.fda.gov/Safety/Recalls/ucm405938.htm. Accessed July 22, 2014.

[6] Food and Drug Administration. FDA alerts health care professionals not to use sterile drugs from Downing Labs (aka NuVision Pharmacy). July 18, 2014. http://www.fda.gov/Drugs/DrugSafety/ucm405940.htm. Accessed July 22, 2014.

[7] Ibid.

[8] Food and Drug Administration. FDA news release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy. August 16, 2013. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm365402.htm. Accessed July 23, 2014.