FDA, Congress should fill the wide gap of responsibility over generic drug safety

A sign advertising generic drugs.A woman walks into a pharmacy to fill a prescription. She is offered either premium-priced drug Brand Name-X or Generic Drug Y, which offers the same treatment at a significantly lower price. She understandably chooses Generic Drug Y. She is not alone, as more than 75 percent of all prescriptions are filled by generic versions of drugs, largely because states require generic substitution which lower health care costs. But many patients are unaware of the lack of accountability that generic drug manufacturers have to warn of safety risks associated with their products.

The manufacturers are not entirely to blame. The federal oversight agency, the Food and Drug Administration (FDA), has created regulatory obstacles preventing manufacturers from adequately warning patients when the manufacturers become aware of potential hazards associated with their products that are not currently addressed on the generic drugs’ labeling. Second, and compounding this safety problem, patients harmed by generic drugs are barred from suing manufacturers of generic drugs. The result is a significant gap in generic drug safety and manufacturer accountability.

In August 2011, Public Citizen submitted a citizen petition (PDF) to the FDA urging it to address the problem. The petition asked the agency to amend its regulations so that manufacturers of generic drugs could revise their products’ labeling to add new information about risks and contraindications, through a revision process currently permitted only for brand-name drug manufacturers.

As experts have noted, all the risks associated with a particular medication are not identifiable until after the product has been on the market for several years. In addition, the majority of approved drugs with distinct ingredients, delivery routes, and strengths are available in generic form. In fact, many drugs are available solely in generic form. Because of their expanding market share, generic drug manufacturers likely receive substantial reports of safety incidents, and have the tools to be fully aware of information suggesting previously unknown risks or other inadequacies in the current labeling.

Unfortunately, the FDA’s failure to keep regulations in pace with the growth of the generic drug market creates a gap in drug safety. 

Adding fuel to the fire is a 2011 Supreme Court decision, Pliva v. Mensing, where the court held that the restrictions imposed by federal law on the ability of generic drug manufacturers to alter labeling preempts state common-law claims against a generic manufacturer based on failure to warn of product hazards. The decision bars patients from seeking compensation in court for injuries caused by generic drugs. Yet, just two years before, in Wyeth v. Levine, the Supreme Court had held that federal regulations did not preempt state-law failure-to-warn claims against brand-name prescription drug manufacturers.

The court’s explanation of the inequity turns on the FDA regulations that do not allow generic drug manufacturers from updating generic drug warning labels. The court in Pliva said that it was “impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”

Preemption of tort suits is harmful, not just for the injured individuals who cannot sue, but for all patients because it leaves responsibility for ensuring drug safety in the FDA’s hands, which cannot protect consumers on its own. Indeed, the Supreme Court noted the FDA’s limited resources to monitor the vast number of products – approximately 11,000 drugs – on the market.

Three years earlier, in holding that patients’ right to sue brand-name drug companies is not preempted, the Supreme Court observed that tort law benefits patients in several ways:

• uncovering unknown drug hazards;

• providing incentives for drug manufacturers to disclose safety risks promptly;

• serving a compensatory function that motivates injured patients to come forward with information.

On Thursday, a House subcommittee will hold a hearing to discuss an agreement between the generic drug industry and the FDA over user fees. User fees are paid by each manufacturer to help support the cost of reviewing generic drug applications. The hearing makes this a good time to remind the FDA and Congress about the generic drug safety gap.

As the generic drug market expands, manufacturers must be given responsibility to patients for the products they sell. Either the FDA must allow these manufacturers to revise labeling to warn of newly discovered risks, or Congress must pass a law giving manufacturers that ability.

Christine Hines is consumer and civil justice counsel at Public Citizen’s Congress Watch division.

Flickr photo via thewendyhouse.