Bring Generic Rules Into the 21st Century

Christopher Glenn, Editor in Chief
4/2/2014

It’s generally estimated that generics account for more than 80 percent of drugs prescribed in the United States. With the continuing pressure on health-care costs, it’s in the government’s (and everyone’s) interest to encourage the use of generics that provide safe and equivalent, lower-cost treatment options to that of branded drugs that have gone off-patent.

This month, Dr. Malik Y. Kahook joins us to address the topic of generics, providing both a concise outline of the current regulatory environment around generics, and some very practical advice on helping patients and physicians navigate the “through the looking glass” world of generic drug rules and regulations.

One of the key contributors to the concern about generic drug safety involves labeling. With good intentions (as always) rules were created   decades ago that required that a generic drug carry the exact same label as the innovator drug that it copies, effectively prohibiting generic drugmakers from updating safety data on their labels unless such changes are made on the original drug’s label.

Compounding the problem is a 2011 Supreme Court ruling that the FDA’s restriction on label changes by generic manufacturers meant that those companies could not be held liable for failure to warn patients about risks. One study revealed that  safety-related label changes may occur a median of 10 to 13 years after a drug’s approval, and as long as many decades after approval. As the original drug has often exited the market, it’s up to the generic manufacturer to monitor safety; and that’s just not happening.

Dr. Kahook takes the optimistic road: “Fortunately, this issue has come to the attention of the FDA. In November 2013, the FDA proposed a rule that would permit generic drug manufacturers to update their labels if they receive information about potential safety concerns. If passed, this will go a long way toward ensuring safety for our patients.”

The legislation was scheduled for review in a House of Representatives early in April. Lining up against the FDA will be the Generic Pharmaceutical Association, which charges that the change will add unnecessary costs, needlessly confuse patients with labeling changes, and lead insurers to decline to cover generic drug companies against liability risks.

Throw in the increasingly common news reports of unsafe imported generics, and you see real reason for concern about what your patients are actually doing once your prescription walks out the door.