Consent Decrees
July 6, 2017
By Devin McElroy

The FDA, this morning, issued a press release for a consent decree issued against Medistat by a U.S. District Judge (see attached article for details).

What is a consent decree and what actions cause one to be issued?
A consent decree is requested by the FDA and issued by a Federal Judge against a company that has had numerous, unresolved violations against U.S. regulations for medical device or pharmaceutical manufacturing. Typically this process starts years before with a series of FDA Form 483 (Notice of Inspection) findings issued against a company that are not resolved to the FDA’s satisfaction. After a few rounds of unresolved issues, the FDA typically next issues a Warning Letter. This Warning Letter typically contains all of the information found during inspections (from the From 483 findings) and the reasons that the proposed manufacturer’s resolutions (if any) were unsatisfactory. The FDA may then go through a couple of rounds of Warning Letters with the offending manufacturer. Once the FDA’s patience has been exhausted, they request the issuance of Consent Decrees to manufacturers. There is no “magic” number of violations that can lead to this course. This is up to the FDA inspector responsible for the manufacturer.

What happens when a consent decree is issued?
The biggest fear is that a consent decree means that the manufacturer must close their doors. This is absolutely not true. What a consent decree outlines is the conditions that the manufacturer must meet before they can continue marketing their product. In order to ensure that these conditions are met, the FDA oversees all operations. The company can continue to operate (internally) as before, but must modify their internal practices to remediate all of the identified areas of deficiency. They must gather proof (evidence—e.g., Quality Records) that they have manufactured product according to all the restrictions placed on them by the FDA and adhered to the restrictions 100%. Once the FDA approves their “proof,” the company may then market their approved products to the U.S.

How can Neozene help these situations?
Neozene, as experts on the FDA’s Quality, Regulatory, and Manufacturing regulations can help provide oversight to companies against whom a consent decree has been issued to interpret, implement, and follow the FDA’s restrictions to the letter that can then go on to help the company amass evidence which leads to their ability to continue to market their products in the U.S.

Other notes:
Consent decrees are only issued by the U.S. FDA and, therefore, only impact U.S. marketing efforts. All products marketed in other countries may still be sold as previous with one big caveat; most countries require that the manufacturer report that a consent decree has been issued against their products and these countries (e.g., Japan, Brazil, and Canada), may similarly apply restrictions against the manufacturer until the consent decree has been lifted.

Consent decrees, although they are “permanent” in nature, are not truly permanent. Once the manufacturer has shown consistent efforts toward compliance, the FDA may go back to a Judge to request that the consent decree be lifted. This is not automatic after a number of years, it is when the particular overseeing FDA Officer decides that the company is 100% compliant with all restrictions and no longer requires oversight. Typically, for companies against whom consent decrees have been issued, this can take anywhere from 5 to 10 years (and sometimes longer).