Makers of Genetic Drugs Challenge the FDA

A New York Times article from March 27 discusses a proposed plan that would require pharmaceutical companies that make generic drugs to update their labels anytime potential health risks are discovered so as to warn consumers. This creates an environment where generic drug companies will legally be held liable for failing to do so and where drug companies will be held responsible for the drugs they create, as well as responsible for warning consumers about their side-effects.

At a Food and Drug Administration meeting, however, the pharmaceutical industry suggested that it should be the F.D.A itself that determines where such warnings are necessary, and if they find that they are, it should be the F.D.A that is in control of ensuring that companies make these labels and any subsequent changes to their drugs. This seems to be a typical example of blame-shifting and groups that are unable to take responsibility for their own products. With the thousands of drug products that are on the market, it seems like an impossible task for one organization to be in charge of determining what risks lie where, and ensuring that pharmaceutical companies warn consumers – this ought to be the responsibility of drug-makers, not some other external group.

According to the article, millions of Americans take generic drugs rather than name-brands and “more than 80 percent of prescriptions in the United States are now filled by generic versions of a drug”. However, current laws make it such that pharmaceutical companies that make these generic drugs cannot update health warnings unless told to do so by the F.D.A. If this seems counter-intuitive, it's because it is. As the law currently holds, pharmaceutical companies that produce brand-name drugs make changes to their drugs when they find risks and potential problems, and it is only when these changes are approved by the F.D.A, that other drug-makers can make changes in their generic labels.

The problem with this is that millions of Americans take generic drugs before the warnings are on their labels, which puts them at risk unknowingly. Because of this, the F.D.A proposed that generic drug-makers have a control over their own labels equal to their brand-name counterparts. It seems logical that if a company doesn't have control over its own labeling, that it can't be held accountable for putting consumers at risk. Allowing generic companies to have control over their own labels would mean that consumers are more or less guaranteed some level of safety when taking generic drugs, and it would also means that these generic companies can be held liable when things go wrong.

However, this move has brought a lot of unexpected resistance. Generic drug companies insist that making themselves liable to lawsuits worth millions of dollars, would only “increase costs for an industry that has helped American consumers save billions of dollars”. They say that because they are not the ones researching the drug and not the ones with decades of data on drugs (as brand-name pharmaceutical companies are), it ought to be the F.D.A (who has unlimited information from both brand-name and generic drug companies as well as consumers) that make these changes. Holding the F.D.A accountable for labeling would be a better system. This argument carries weight but also carries many issues – the fact is that the F.D.A cannot be in charge of labeling for specific companies and specific drugs; only drug-makers can be held liable for their own drugs and only drug-makers know the full extent of the effects of their drugs.

When it comes to safety issues and legal obligations, perhaps, we should think first of the consumer whose life and well-being is in danger, before focusing on the legal jargon and legalese of certain laws and terms. Drug companies ought to be held liable for their products and not be protected from liability merely because they provide a good service; in fact, they ought to be held more liable because of the fact that so many individuals rely on them. It seems like a weak and counter-intuitive argument to say that merely because so many people rely on a product, that the company that provides the product ought to not be held liable.

References:

1. http://www.nytimes.com/2015/03/28/science/makers-of-generic-drugs-challenge-fda-plan-for-updated-warnings.html?ref=health&_r=0