On October 18, 2016, the United States Food and Drug Administration (FDA) proposed withdrawing two generic versions of Concerta. The FDA ran tests on both drugs and it was determined they had insufficient effects on patients. The drug, Concerta, is alleged to have a number of side effects on people who take it including suicide, agitation, convulsions, disturbed sleep, hallucinations, hostility, stroke, anxiety, depression, drug addiction/abuse, heart issues, mania, and psychosis. The two drug manufacturers are Kremers Urban (subsidiary of the Lannett Company), and Mallinckrodt Pharmaceuticals, which were both given opportunities to request a hearing by the FDA to show why their drugs shouldn’t be withdrawn. Ordinarily, a move like this from the FDA would lead to a flurry of lawsuits.
Patients cannot sue the manufacturers relating to efficacy or labeling of the drug. Also, because they are generic manufacturers, the companies cannot change the formula or labels on their own even if new information about safety and side effects are discovered. The United States Supreme Court upheld this idea in a 5 to 4 decision that overturned a New Hampshire jury verdict; the verdict awarded over $20 million to a woman who took a generic version of a drug. Generic drugs exist to help consumers save money on buying drugs they need to treat illnesses. According to the Congressional Budget Office, generic drugs help consumers save an estimated $8 to $10 billion at retail pharmacies. Institutions like hospitals and clinics save billions when they use generic drugs.
According to the FDA, a generic drug is developed under patent protection when it is first created. This gives the company the sole right to sell the drug while the patent is in effect, essentially giving it a monopoly on the market. Once the patent wears off, generics can enter the market submitting their new drug application for approval. The Orange Book provides a way to look up generic versions of brand name drugs. Concerta is manufactured by Janssen (subsidiary of Johnson & Johnson). It is used to treat Attention Deficit Hyperactive Disorder (ADHD).