Consumers Apparently Still Have Confidence in Generics
WASHINGTON (AP) _ Consumer advocates and physicians say there’s no reason to doubt the safety and effectiveness of most generic drugs, and consumers appear to be heeding that advice.
″I don’t think there’s panic in the streets. I think they’re concerned,″ said Harold Cohen, editor of the trade publication Drug Store News-Inside Pharmacy, referring to drug consumers.
Cohen, who has been visiting pharmacies in St. Louis, Phoenix and Washington D.C. for the past week, said Monday he saw few customers switching from a generic to a brand-name drug.
″As far as we know there is no problem with safety at this time and no problem that is one that would make people stop taking generic drugs,″ Dr. Frank Young, commissioner of the Food and Drug Administration, said today.
″If you are concerned, see your physician, but don’t switch without really checking with someone first,″ he said on ″CBS This Morning.″
Disclosures of fraud and corruption in the FDA’s generic drug division have tainted the agency’s reputation and cast doubts on the industry as well as the safety and efficacy of generic medicines.
″We are just as shocked, dismayed and angry as I think consumers are with the despicable events that were perpetrated by a few generic companies,″ Young said, adding that ″we’re not going to rest until this is cleaned up.″
Young’s assurances of the safety of generics echoed those of other physicians and consumer advocates.
″At the present time, there’s no evidence that any generic drugs out there in the pharmacies lack safety or effectiveness,″ said Dr. Sidney Wolfe, head of the Public Citizen Health Research Group.
Dr. Ray W. Gifford, a trustee of the American Medical Association who is also an internist at the Cleveland Clinic and a clinical pharmacologist, agreed.
″What we’ve seen in the past few weeks is regrettable, but I don’t think it reflects all generics and it really hasn’t changed my prescribing habits,″ he said.
However, Gifford said, most physicians already insist on brand-name drugs for certain hard-to-treat conditions, such as congestive heart failure.
″There doesn’t seem to be a surge of phone calls or people bringing back bags of drugs,″ said James Krahulec, vice president of government affairs for Rite Aid, the nation’s largest drugstore chain.
Krahulec said his chain was surveying its nearly 2,300 stores to gauge public reaction to the scandal enveloping the generic drug industry, but ″no one has called in with panic information.″
The FDA has initiated steps in the past month to pull from the market products manufactured by several generic drug companies.
In the latest move, the agency said Monday it wants to remove Bolar Pharmaceuticals Co. Inc.’s generic version of Dyazide, a popular drug used to treat high blood pressure. The FDA said it found no evidence of fraud.
The Copiague, N.Y.-based Bolar, which says it will appeal within the 30-day limit, said the problem stems from confusion over a clerical error in identification of samples used in safety tests.
The FDA also has expanded federal inspections of 11 generic drug makers to include the plants of 20 additional generic companies and is reviewing 30 of the most commonly used generic drugs.
The main question raised about the drugs is whether they work as effectively as the brand-name drug - whether they are absorbed into the body at the same rate as the drug they mimic.
Wolfe said potency problems were rarely of any significance. In most cases, he said, doctors prescribe the same dose of medicine for a 125-pound adult as for a 250-pound adult.
″For most drugs, there is a wide range over which the drug will be effective and safe,″ he said. ″This cuts through a lot of the extent to which people are overreacting to the problems that have been brought to light.″
Generic drugs are copies of brand-name medicines and are usually much less expensive. A third of all prescriptions written in the United States are filled with generic drugs, according to the Generic Pharmaceutical Industry Association.