FDA and Generic Drug Labeling News

On Tuesday, April 1, 2014, the Food and Drug Administration defended a proposal it had created that would require generic drug makers to update information on prescribing the drugs on their products. This change comes as a result of new safety information coming to light. In response, the industry states that it would potentially create product liability, increased drug costs and lawsuits.

Dr. Janet Woodcock, a top pharmaceutical official at the FDA spoke at a hearing before the United States House of Representatives and said that the change is required so that parity could be created between generic and brand name drugs with regard to label changes.

Currently, makers of generic drugs are allowed to change the labels on their products and do not require approval of the agency because they are supposed to be identical to the brand name drugs that are the same. The branded company is required to make any changes and manufacturers of generic drugs are supposed to do the same.

The requirement dates back to the Hatch-Waxman Act from 1984. This act stated that manufacturers of generic drugs did not have to engage in costly lab experiments to show that their medications would have the same effect on people as those that carried brand names. For years, the FDA insisted that only the brand name companies be required to update labels on its drugs.

However, in 2011, the Supreme Court ruled that this meant that makers of generic drugs could not be held accountable if some risk occurred as a result of a patient taking it. In other words, if a patient were to become injured as a result of taking a brand name medication, they would have legal recourse. On the other hand , if they were taking one that was the same in nature but carried a generic name, they would have none.

Now, the FDA wants to allow and require generic drug makers to make these changes and include warnings on its labels.

Over 80 percent of prescriptions written in the United States are written for generic drugs. In as many as 45 percent of cases, the branded drug is unavailable at this time, meaning that the brand name company is not responsible for updating data about the safety or risks of the drug. Dr. Woodcock stated that the proposal would require both brand name and generic drug manufacturers to support their products by updating any risks or side effects that may be associated with them.

Generic drug manufacturers are against the proposal. Ralph Neas, the President of the Generic Pharmaceutical Association, stated that it would open up a whole slew of new liability cases and require a change in prices for generic drug makers to stay in business.