My name is Dr. Anna Mazzucco. Thank you for the opportunity to speak today on behalf of the National Center for Health Research. After completing my Ph.D. at Harvard Medical School, I conducted research at the National Institutes of Health before joining the Center’s staff. Our research center conducts research, analyzes data in the research literature, and then explains the evidence of risks and benefits to health professionals, patients, and policymakers. Our president is on the Board of Directors of the Alliance for a Stronger FDA, which is a nonprofit dedicated to increasing the FDA’s budget, so that it can do its job well. Those are the perspectives I bring today.
Our organization does not accept funding from pharmaceutical companies, and therefore I have no conflicts of interest.
The FDA stated that their proposal is intended to “ensure that generic drug companies actively participate with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling.” This is the heart of the matter before you today.
As FDA noted, when generic versions are available, it is the generic version that is dispensed 94% of the time. This proposal has implications for millions of Americans who assume that they have the same legal protections and most up-to-date information, regardless of whether their drug is a brand name or not.
The current situation creates a terrible double standard, making patient with generic drugs second class citizens. And, when brand name drug manufacturers leave the market after generics become available, nobody is held responsible for updating the label. This is completely unacceptable.
The proposed rule applies equally to brand name drugs and generic drugs. This is consistent with current law, since brand name and generic drug companies are already “required to conduct surveillance, evaluation, and reporting of postmarketing adverse drug experiences” and, if necessary, propose revisions to the drug’s labeling. This proposal would ensure that those responsibilities are brought across the finish line to patients.
Some may argue that by the time generic versions enter the market, any safety issues with the brand name version should be well known. From the FDA’s own study, we know that is not true. Unfortunately, the FDA found that the median time from initial approval of the drug product to the time of making a safety-related labeling change was 11 years.
Generic drug makers and some others have speculated that allowing generic companies to initiate labeling changes will cause confusion among patients. We strongly disagree: Patients are smart enough to understand why different labels may differ.
Even so, the FDA’s addresses those concerns by requiring generic and brand name companies to begin the process with FDA to harmonize their labeling within 30 days. The FDA also proposes to establish a Web page where the FDA would promptly post information regarding the labeling changes proposed. The Web page would provide information about safety-related labeling changes and a description of the proposed labeling changes and the source of the information for them, such as adverse event reports, journal articles, clinical trials, or epidemiologic studies. The new final labeling will be posted on the FDA Web page.
We completely agree with the FDA that concerns about temporary differences in labeling between generic drugs and brand named drugs are outweighed by the benefit to the public health that comes from updating labels with drug safety information.
The proposed rule will save lives and improve the quality of lives of patients who take generic drugs. It will provide the most current information about the risks, hazards and side effects of drugs—crucial information for patients and their health care providers. Patients have told us that they expect that information from the FDA.
And we strongly agree that patients deserve that information.