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FDA Looking at Generic Blood Pressure Drugs

Yesterday, it was reported in the news that the FDA is looking at the effectiveness of generic blood pressure drugs, mostly copies of AstraZeneca’s Toprol XL.  Because many of the generics sold in the United States come out of Indian plants, the question of generic effectiveness has merged with concerns over the quality standards of some drug makers. Sandy Walsh, a spokeswoman for the FDA, said the FDA also has rethought the criteria that was used for approval of the generics.  This is a big issue.

Today, nearly 8 in 10 prescriptions filled in the United States are for generic drugs.  This number is expected to grow as many drugs are expected to come off patent in the year 2015.  Many times your doctor will prescribe a generic or your pharmacy will automatically switch your prescription to a generic drug unbeknownst to you.

Are the generic drugs the same?  Not necessarily. Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product.  This is what is known as “bioequivalence” in the drug industry.  When a generic drug is “bioequivalent” to the brand-name drug, it means that the FDA has determined that the generic drug works the same as the brand equivalent and after administration of a standard dosage, blood levels of the generic drug are the same as for the branded original.  But although the generic’s mean maximal concentration and area under the concentration-time curve are typically within a few percentage points of the original’s — typically about 4% — the 90% confidence interval for those results means the generics can be as much as 20% below or 25% above the brand name drug’s mean.

Right now, the FDA does not have the authority to require generic drug makers to do post marketing studies on the bioequivalency of their copies.  Maybe it should.  Stricter bioequivalence rules need to be in place to protect patients, in light of the fact that most people are taking generic drugs if they are available.  The confidence interval may be okay for some drugs, but not for other drugs that treat serious illnesses.  The FDA and the public should insist that generic drug makers have more responsibility to patients in light of how widely they are prescribed and their generation of revenue.

Claudine Q. Homolash, Esquire, founder of the CQH Firm, is a whistleblower, pharmaceutical injury and personal injury lawyer representing clients nationwide.  She can be contacted at 1-(844) 677-4276 or (215) 496-1012 or by email at for a free legal consultation.

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