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Two Unapproved Drug Manufacturers File Lawsuit Against FDA

As our readers know, LegitScript has recently been taking a look at another aspect of drug safety: the dispensing of unapproved drugs, both online and offline. In this regard, a recent lawsuit filed by two drug manufacturers against the FDA will be interesting to watch.

On their FDA Law Blog, the firm of Hyman, Phelps and McNamara note the recent filing of a lawsuit by two makers of morphine sulfate, Cody Laboratories and Lannett Co. As the Hyman firm explains:

The lawsuit is (to our knowledge) the first challenge arising from FDA’s Unapproved Drugs Initiative, which was kicked off in June 2006 with the publication of the Agency’s Compliance Policy Guide (“CPG”)…The Cody/Lannett lawsuit stems from FDA’s March 2009 decision to issue Warning Letters to nine companies, including Cody and Lannett, to stop manufacturing fourteen unapproved narcotic drugs, such as high concentrate morphine sulfate oral solutions, morphine sulfate immediate release tablets, hydromorphone, and oxycodone. At that time, FDA concluded that marketed unapproved morphine sulfate products are “new drugs [under the FDCA] and not grandfathered and that manufacturing and marketing of these products without an approved application constituted a violation of the Act.”

Understanding the history. Understanding the relevance of this lawsuit requires understanding the history of the FDA’s unapproved drug initiative. Much of the current drug approval process was formed in 1962. At that time, drugs that were already on the market were allowed to be “grandfathered in” – meaning, they could lawfully be dispensed by pharmacies without going through the FDA approval process, until and unless there was some change in formulation, labeling, et cetera, to the drug. That made a lot of sense, at first. But today, being that nearly 50 years have since passed, the FDA’s position has increasingly been that very few drugs will likely meet the criteria for “grandfathering.”

What this means for patients. To put this in layman’s terms, let’s say that you have a prescription for morphine sulfate. There are a variety of formulations and strengths of the drug: not all morphine products are the same. The FDA has reviewed and approved a few of these, but other formulations are not approved and thus, may not be safe and effective. But in some cases, the manufacturers have argued that if they’ve been making the same product since before 1962, they should be considered “grandfathered in,” and the drug shouldn’t have to go through the FDA drug approval process, which can be lengthy and costly. In this particular case, the FDA had sent a warning letter to the manufacturers, stating that their version of the drug is “unapproved.”

What to watch for. While it would be premature for us to venture an opinion on a pending lawsuit, it does raise a variety of interesting issues. Regardless of which way the lawsuit goes, a few important principles come into play.

# First, as a matter of general principle, it’s important not to weaken the FDA’s ability to enforce existing laws and regulations, particularly regarding unapproved drugs. Whatever the merits of this particular case, a decision that would chill the FDA’s ability to require that only safe, effective medications be dispensed could be disadvantageous to patients in the long run.
# Second, as a general matter, this highlights the fact that drugs considered by the FDA to be “unapproved” (and thus not necessarily safe or effective) are, apparently, still being manufactured and are presumably being dispensed to patients. Indeed, a recent article suggested that nearly 75 million prescriptions dispensed each year in the US may be for drugs considered by the FDA to be unapproved.
# Third, again without reference to this specific case, it would seem axiomatic that as our collective knowledge of chemistry, drug safety and medicine improves, we should expect that in most or all cases, the exact formulation of a drug available in 1960 is probably not going to be the best that’s potentially available in 2010, fifty years later. Indeed, it is possible to conceive of a situation in which an anti-FDA decision would actually incentivize manufacturers not to make needed updates to drug formulations.

LegitScript will continue to watch and report on developments in this area over the next several months.