Defending FDA: Agency Requires Critical Funding To Protect Consumer Health, Safety

Go online today, and there's a pretty good chance you'll be bombarded with ads for "cheap prescription drugs" from online pharmacies promising bargain basement prices. Consumers can't be blamed for clicking on these advertisements in attempts to find the best deals available for themselves and their families. But oftentimes these sites are distribution centers for unregulated, illegally imported, and even counterfeit prescription medications.

The Food and Drug Administration (FDA), through its Office of Criminal Investigations (OCI), works to investigate and shut down pharmacies that are operating outside the law. OCI operates on the front lines of consumer protection, ensuring product safety and integrity of life-saving medications for American patients.

Many online pharmacies present themselves as a legal, safe, and often less expensive alternative to purchasing medications from a retail or mail-order pharmacy. But in reality, they may be selling drugs that contain the wrong active ingredient, the wrong amount of the active ingredient, no active ingredient, harmful ingredients, or even poisons such as mercury, road tar, or antifreeze.

According to the FDA, earlier this year, as part of Operation Pangea IX, a global cooperative effort led by INTERPOL, "FDA inspectors ... screened and seized illegal drug products received through International Mail Facilities (IMF) in San Francisco, Chicago, and New York. These screenings resulted in the detention of 797 parcels ... The FDA's Office of Criminal Investigations ... participated in the enforcement action ... and sent formal complaints to domain registrars requesting the suspension of the 4,402 websites." The investigation found that American consumers were being prescribed and treated with illegal and unsafe medications without knowing it.

FDA noted: "... Preliminary findings from drug products screened at the IMFs show that U.S. consumers had purchased certain unapproved drug products from abroad to treat depression, narcolepsy, high cholesterol, glaucoma, and asthma, among other diseases."

Illicit Botox has also been a target of OCI investigations, after four patients became paralyzed after receiving injections of fake versions of the drug in Broward County, Florida in 2004. As a result, 31 individuals were arrested for administering fake or unapproved Botox to nearly 1,000 patients. While the agency has been criticized recently about its management and handling of cases involving food, drugs, and devices, it's crucial that consumer protections, as set by the FDA, are upheld and enforced to the highest standard.

As U.S. District Court Judge Esther Salas remarked at a recent sentencing following an OCI-conducted investigation into adulterated and misbranded dietary supplements, "There is nothing more sacred than consumers having some peace of mind that people who are selling these supplements are doing it the right way, and are abiding by the laws and regulations that are put forth to protect the consumer. . . Because what the FDA does is so critical...they are making sure that the products that we consume and the products that we use are safe for consumption, are safe for usage."

Unfortunately, FDA has become a Congressional target in recent years, and the OCI is no exception. The House Energy and Commerce Committee sent a letter on September 20 inquiring about management and oversight at OCI, which some press reports have noted "could be the first step in congressional efforts to get rid of the OCI entirely."

There's no doubt that, like any federal agency, improvements can and should be made to the OCI. Yet it's also clear that the office performs a crucial function within the agency to keep consumers safe and ensure bad actors are prosecuted to the fullest extent of the law. That mission is an expensive one, and the FDA and, within it, the OCI, have always been underfunded.

As a member of the Alliance for a Stronger FDA, the National Consumers League has been at the forefront of advocating for appropriate levels of funding for the FDA. The Alliance has noted in the past that robust, publicly-accountable decision-making is resource intensive. It's essential that any increased expectations placed on the OCI by Congress be sufficiently supported with adequate funding.

As the nation's pioneer consumer organization, the National Consumers League works hard to keep our regulators and elected officials accountable to the public while continuing to educate and empower consumers on safe use of medications and helping them avoid falling victim to counterfeit drugs. At the same time, we also need to make sure agencies like the FDA are able to execute their duties as protectors of the public health. It's been a core principle of NCL for more than 100 years, and it's exactly what Americans deserve today.