Generic Drug Industry Still Largely Unchecked

In the past few months, this blog has addressed issues concerning the safety of generic drugs. In July we published an article about the Supreme Court protecting manufacturers of generics in cases in which victims were harmed due to inadequate warning labels. Fortunately, the FDA stepped in to try to impose stricter standards on such labels, attempting to circumvent the Court’s decision.

More recently, the Center for Justice and Democracy at New York Law School closed out 2013 with a white paper entitled “America’s Unaccountable Generic Drug Industry: How Legal Immunity Could Be Making You Sick” by Jocelyn Bogdan. Despite its somewhat sensational title, the report is full of useful and even startling information about the ways in which the manufacturers of generic drugs may be putting Americans’ health at risk, and this is especially relevant because 80 percent of prescriptions filled in this country are for generic drugs.

The first revelation in the publication is the FDA’s former Generic Drug Officer, who claims that “drug applications work on the honor system” in which “the FDA relies on data provided by the [pharmaceutical] companies themselves.” He goes on to admit that the FDA “depend[s] on that information to be truthful […], otherwise, the whole house of cards will fall down.” This statement seems to be an admission of the FDA’s failure to regulate such companies, as there is little doubt that these corporations are more concerned with their own profits than the safety of individuals taking their products.

The report explains that as it stands now, generic versions of a brand-name drug provide a definite benefit for most consumers; they are cheaper and usually serve the exact same function as their more expensive counterparts. But the Supreme Court has decided in 2011 and again in 2013 that even if a “clinically significant hazard” a generic drug manufacturer will not be held accountable in court when a consumer is injured or dies after using a drug that contains inaccurate or inadequate labeling or design. In other words, “whether or not an injured patient has any legal recourse depends entirely on whether [he or she has] been prescribed a brand-name or generic drug,” which is a decision over which patients have little control.

Another argument in the paper is that off-brand drugs are much more likely than the costlier ones to be made in countries like China and India, where quality control standards are not as strict as those in the United States. Accordingly, they are often made with ingredients that are of lower quality than those manufactured in this country.

The author of this publication, Jocelyn Bogdan, also explains that in order for a generic drug to make it to market, it must be administered to dozens of volunteers–as opposed to tens of thousands for a brand-name drug. Moreover, generics must be “bioequivalent” to brand-name drugs, but that means their concentration in an individual’s blood must be 20 percent below or 25 percent above that of a brand-name medication. As Bogdan writes, “This means a potential range of 45 percent” concentration in the blood, a very broad margin that hardly sounds as if it is worthy of the “bioequivalent” categorization.

While the FDA has introduced an improved labeling and approval system, it is one that will likely be met with resistance from the pharmaceutical industry.