U.S. House of Representatives
Washington, DC 20515
Dear Representative ________
The National Center for Health Research strongly urges you to remove the anti-consumer language from the House Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill for fiscal year 2017. The language (Section 747) was added at the 11th hour and it would prevent the FDA from finalizing its proposed rule on generic drugs labeling.[1]
The proposed rule will save lives because it would clarify that generic drug manufacturers are responsible for safety updates for their drugs. Safety information is required on drug labels, so that physicians and patients know what side effects are dangerous and which ones are not. It would enable generic drug manufacturers to revise drug labeling through the same process that brand-name manufacturers have used since the 1980s. Extending this process to generic drug manufacturers will give physicians, patients, and their family members access to more accurate information about the risks and benefits of the medications, regardless of whether a drug is brand-name or generic.
The FDA has noted that when generic versions are available, generic versions are used 94% of the time, and brand name drugs are used only 6% of the time. If these labels are not updated as soon as safety issues arise, millions of Americans lack the safety information they need to avoid dangerous and potentially fatal side effects.
The current situation creates an unsafe double standard, making patients taking generic drugs second class citizens. All Americans should have the same legal protections and most up-to-date information, regardless of whether their drug is a brand name or generic. And, when brand name drug manufacturers leave the market after generics become available, nobody is currently held responsible for updating the label.
Some argue that by the time generic versions enter the market, any safety issues with the brand name version should be well known. That is not true. The FDA found that the median time for safety-related labeling changes is 11 years after the initial approval of a drug, a point at which the generic version of a drug is often more widely used than the branded version
Generic drug makers have speculated that allowing generic companies to initiate labeling changes will cause confusion among patients. This is a self-serving excuse for avoiding responsibility for warning patients about risks. Any temporary differences in labeling between generic drugs and brand named drugs are outweighed by the benefit to patients that comes from updating labels with drug safety information. The proposed rule is pro-public health and pro-consumer. We strongly urge you to remove the language from the Appropriations bill that would prevent the FDA from finalizing its proposed rule on generic drug safety labeling.
The National Center for Health Research
The National Center for Health Research can be reached through Paul Brown at (202) 223-4000 or at pb@center4research.org
- Supplemental Applications Proposing Labeling Changes for approved Drugs and Biological Products rule. Docket No. FDA-2013-N-0500