Readers of our blog are familiar with the 510(k) clearance protocol used by the United States Food and Drug Administration (FDA) to bring “substantially equivalent” medical devices to market that carry a similarity to products already on the market and performing within expectations (see, Hip Replacement Failures and the FDA’s 510(k) Expedited Device Clearance Process). Since the 1970s, this protocol allows a manufacturer to escape the lengthy and often cost-prohibitive clinical trial process normally required to bring a new product to market. Instead, substantive equivalency assumes there are sufficient similarities to pre-existing products, which lead to a determination that intensive pre-market clinical testing is not required. While post-market testing may be required after product release, 510(k) clearance is designed to bring promising products and updates to the market sooner than otherwise expected under traditional protocols.
A similar expedited approval process has also been available for more than 30 years for pharmaceuticals. The 505(b)(2) New Drug Application (NDA) protocol is a hybrid application that is used to seek approval for a new formulation of a drug, while relying on data with regard to the safety and efficacy of an active ingredient previously submitted to the FDA with regard to a pre-existing drug. The idea is that the 505(b)(2) applicant is not required to duplicate data that’s already publicized, thereby saving on costs and suggesting a capacity to get a promising drug to the market sooner.
Drugs approved under 505(b)(2) can rely on certain data from existing reference drugs. This means they can be developed and achieve FDA approval in as little as 30 months with only a fraction of the number of required clinical trials and at much lower cost. Unlike generic drugs approved under Section 505(j), where exclusivity can be held for only 180 days, the 505(b)(2) applicant may qualify for three, five, or seven years of market exclusivity, depending on the extent of the change to the previously approved drug and the type of clinical data included in the NDA. Patent protection may allow companies to recoup the substantial development costs and provide profits to support further research efforts.
Regardless of the regulatory pathway chosen for NDA approval, FDA standards for the demonstration of efficacy and safety are the same — it is only the source of information that differs between the two paths. It is important to understand what constitutes sufficient evidence and which specific studies can be replaced by existing data for individual compounds.
Once a product is in widespread use, unforeseen problems can sometimes lead to a recall. When an FDA-regulated product is either defective or potentially harmful, recalling that product, which involves removing the product from the market, is the most effective means for protecting the public. Recalls are almost always voluntary. Sometimes a company discovers a problem and recalls a product on its own. Other times a company recalls a product after FDA raises concerns. Only in rare cases will FDA request a recall. In either case, the FDA’s role is to oversee a company’s strategy and assess the adequacy of the recall.
FDA-regulated products subject to recall are:
- human drugs
- animal drugs
- medical devices
- radiation-emitting products
- blood and blood products
- transplantable human tissue
- animal feed
- about 80 percent of the foods eaten in the United States
The FDA first becomes aware of a problem product in several ways:
- A company discovers a problem and contacts FDA
- The FDA inspects a manufacturing facility and determines the potential for a recall
- The FDA receives reports of health problems through various reporting systems
- The Centers for Disease Control and Prevention (CDC) contacts FDA
The FDA seeks publicity about a recall only when it believes the public needs to be alerted to a serious hazard. When a recalled product has been widely distributed, the news media is a very effective way to reach large numbers of people, including press conferences, press releases, and regular updates to the FDA website. Though not all recalls are announced in the media, all recalls are mentioned in the FDA’s weekly Enforcement Report, which lists each recall according to classification, with the specific action taken by the recalling firm.
Recalls are classified as follows, according to the level of hazard involved:
- Class I: Dangerous or defective products that predictably could cause serious health problems or death
- Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature
- Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws
The FDA evaluates whether all reasonable efforts have been made by the recalling company to remove or correct a product. A recall is considered complete after all of the company’s corrective actions are reviewed and deemed acceptable by the FDA. After a recall is completed, the FDA ensures that the product is destroyed or suitably reconditioned, and investigates why the product was initially defective.