May 27th, 2015|
Consumer advocates are urging the public to join the effort to improve the safety warnings for generic prescription drugs. Consumers who support improved safety warnings are urged to sign a Petition to Make Drugs Safer. The majority of prescription drugs dispensed in the U.S. are generic drugs, and the companies that market them are not subject to the same warning label rules as their name brand counterparts. Generic drugs are marketed as offering the same active ingredients and quality as their name-brand equivalents at a lower cost, which makes them a popular choice among consumers and doctors. In fact, more than 80% of prescriptions filled in the U.S. are generic drugs. Many insurance policies require pharmacists to fill prescriptions with generics. The Food and Drug Administration (FDA) regulates the manufacture and distribution of both branded and generic drugs, but does not hold manufacturers to the same standards. Brand name manufacturers are accountable for updating labeling to reflect any new side effects or drug reactions immediately after they are discovered, but laws governing the labeling of generic drugs are much more relaxed.
The modern system of generic drug regulation was created by Congress in 1984. Generic drug manufacturers can get quick approval for their generic drugs as long as the manufacturers can prove the generic drug is chemically equal to the branded original drug. Generic drug manufacturers are not required to perform testing of their drugs, and the generic drug warnings just have to be the same as warning on the branded original.
This loophole puts consumers at risk when new drug injuries and dangerous side effects are discovered. Generic drug manufacturers are not held accountable for updating the warning labels on their products. Brand name drug makers must change the labels for the original drugs before generic manufacturers can begin the process of changing their labels, causing a time lag in getting safety warning information to the users of generic drugs! If a brand name drug goes off the market, but the generic equivalent does not, the manufacturers of the generic drug are not able to change their labeling, even if the drug is known to have new risks. Essentially, generic drug manufacturers can sell their products to unsuspecting consumers even if they know they are dangerous.
The FDA has proposed a rule change that would require generic drug companies to follow the same process as name brand drug manufacturers to update warning labels. Under this fix, generic drug manufacturers would also be held responsible for injuries caused by their drugs in court. Cory Watson Attorneys has partnered with the Take Back Justice campaign to close the loopholes in FDA drug regulation to protect consumers. The rule change has been delayed once already and the Take Back Justice campaign has launched a petition to urge the FDA to take action and hold all drug companies accountable for providing current and accurate labeling on all drugs.
Please join Cory Watson Attorneys in supporting safer drug labeling. Click here today to sign the petition to make generic drugs safer. The period for public comment ends April 27, 2015, so act today to make the marketplace safer for all.