Strengthening the FDA
Two weeks ago, I wrote a post about a couple of major points in the history of the Food and Drug Administration (FDA) and how they redefined the responsibilities of the agency. These events set up the clinical trial process, and gave the FDA the authority to insist that consumable items be both safe and effective before they could be widely sold in the United States. What the FDA has not gained in its history, however, is the ability to recall products in the market that may have proven to be dangerous after their approval.
Well, according to a report I found on the Boston.com site entitled “Panel urges recall authority for FDA,” we may be witnessing history again. Recent recalls of dangerous toothpaste, toys and dog food prompted the creation of an advisory commission by the Bush administration to examine the incidents more closely and determine ways to better handle similar incidents in the future. As a result of their findings, the commission will advise to President Bush that the Food and Drug Administration be “empowered to order mandatory recalls of products deemed a risk to consumers.” (1)
The FDA has no such authority now, and the current process requires that the organization work with manufacturers on voluntary recalls. The agency currently depends on warnings and bad publicity for the offending company in order to get a product removed from the market. This kind of process, however, could take time, and the committee believes that threat of legal action and fines could prompt a quicker response from offending companies.
Complementary to the recommended changes to the FDA, the panel urges the increased presence of U.S. Inspectors at agencies responsible for products imported into the United States, such as the Customs office and the Border Patrol, and increased authority for the Consumer Product Safety Commission (CPSC). The changes to the CPSC are particularly far-reaching, allowing the agency to make it illegal for a firm to knowingly sell a recalled product, authorizing it to make follow-up recall announcements and requiring companies issuing a recall to report supplier and delivery information. The CPSC would have the legal authority to impose fines and other punishments for those companies that did not comply with the new recall guidelines.
According to the report, which you can read here, the reason for encouraging this increased authority is the staggering increase in imports into the United States since 2000. It claims that imports will triple by 2015 with increased demand from Americans of foreign products. The burden of these changes will require more scrutiny from import gatekeepers such as the CPSC, and more clout from the FDA if dangerous materials do make it to market.
When I first read this article, I believed the recommendations of the committee were a bit overzealous, and would increase the bureaucratic “red tape” required to bring good products to consumers. However, given the increased number of variables that imports may introduce that are beyond the FDA’s control, it may not be a bad idea to improve the structure of their authority. Clearly, under its current setup the FDA requires some changes to give it a better handle of the current market, and prevent the kinds of mistakes that have lead to big product recalls of both food and drug products in recent history. After all, I had just assumed the FDA had the ability to recall products; I did not know that only the manufacturers could do so.
Additionally, I’d be curious to know if the FDA’s recall authority is inclusive of both food and drug products, or if it’s just food products. In recent memory, recalls of Bextra, Vioxx, and children’s cough & cold medicines have all be voluntary, indicating to me that they may not have that authority. In the new system proposed by the advisory committee, would companies still be given the opportunity to recall their products first? To me, it’s more impressive if a company knowingly recalls its own products than if the FDA requires them to do so. The former indicates a concern for the company’s customers’ health, and an understanding of the legal ramifications of continued sale of their recalled products. I would likely still buy other products from that company, products proven to be safe. The latter scenario would project a company unwilling to take responsibility for its actions, such that it needs to be told what to do, like a parent to a child. It would be enough for me to cease buying any products from that company.
How do you feel about this? How would an FDA-mandated recall change your opinion of a company? Should companies be given the opportunity to recall dangerous items on their own? How long do you give the companies before the FDA should step in? 24 hours? 8 hours? As always, your thoughts are welcome.
(1) See “Panel urges recall authority for FDA,” by Terrence Hunt, AP White House Correspondent, published on Boston.com, November 5, 2007.
