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Drug Maker Fighting FDA Efforts to Approve Generic Abilify

Prescription drug safety is already a complex issue. There are legitimate questions about the Food and Drug Administration’s (FDA) reliance on manufacturer funded studies in making approval. There is a serious real world problem of prescription and pharmacy error, particularly as large scale pharmacies pressure pharmacists to work faster and faster. In this complex framework the FDA sometimes takes steps that actually help consumers, like approving substantially cheaper generic counterparts to extremely expensive prescription drugs. However, name-brand drug manufacturers are now fighting back, and they are going to court to do it over a generic version of Abilify.

What is Abilify?

Abilify is an antipsychotic medication that changes the actions of chemicals in the brain. It is used to treat mental health conditions like schizophrenia and bipolar disorder. It is also used in children who are often too young to be accurately diagnosed with specific mental health conditions for symptoms like aggression and self-injury associated with autism spectrum disorder.

Drug Maker Takes FDA to Court Over Generic Abilify

A brand-name drug manufacturer called Otsuka Pharmaceutical has sued the FDA, arguing that the agency should not be allowed to approve a generic version of Abilify. Abilify generated $4.9 billion in sales for Otsuka last year according to a report by The Wall Street Journal. Otsuka’s patent on Abilify is about to expire, meaning that if generic versions of the pill are approved by the FDA the company could finally face some competition in the marketplace, likely driving down costs for consumers.

Back in December the FDA approved Abilify for treating children with Tourette syndrome. Because of incentives in place that encourage drug makers to make drugs for rare diseases like childhood Tourette syndrome, this could give Otsuka seven more years of exclusive marketing. But then the FDA approved the drug to treat Tourette syndrome in adults, a move which Abilify never requested. The FDA has backed off on approving the drug for adults with Tourette syndrome, but has still indicated it may yet approve generic versions of Abilify. So the battle is over whether this one small use for Abilify and the extended protection from generic competition that comes with it should apply to the whole Abilify market, or just the market for treating childhood Tourette syndrome.

Safety of Generic Drugs

Keeping the generic drug off the market is a money concern for Otsuka. Its concerns have nothing to do with patient safety. The question remains, are generic drugs as safe as their name-brand counterparts? According to the Food and Drug Administration, the answer is yes. According to the agency’s statistics 80% of prescriptions filled in the United States are filled with generic drugs. These drugs are required by the agency to have the same active ingredient, strength, dosage form, and route of administration as the brand-name equivalent. One thing you make want to be sure of, however, is that you get the correct drug. Drugs that have generic equivalents may have many generic equivalents with a wide variety of names, and your doctor may not be familiar with all of them. So be sure to double check with your pharmacist when you get a generic drug that you are getting the correct one.

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