Pharmaceutical companies spend millions of dollars and thousands of hours on research and development to produce a prescription drug that meets FDA’s approval. For a new drug, the approval process is known as a New Drug Application (NDA). These new drugs, also known as pioneer drugs, enjoy a period of market exclusivity for the manufacturer’s efforts. As their exclusivity ends, generic versions of the products are approved through FDA’s abbreviated new drug application (ANDA). Generic drugs must be bioequivalent and meet similar safety and efficacy requirements to the pioneer drug.
Recently, pharmacists and patients have noticed a change in the effectiveness of a generic drug for the treatment of attention deficit hyperactive disorder (ADHD). In December 2013, FDA Adverse Events Reporting System warned that certain methylphenidate hydrochloride extended-release tablets (generic products for the trade name Concerta) lacked therapeutic effect and possibly related product quality issues. In November 2014, FDA issued a draft guidance for industry entitled “Bioequivalence Recommendations for Concerta (methylphenidate hydrochloride) Extended-Release Tablets.” The recommendations provide specific guidance on the design of bioequivalence studies to support ANDAs that reference the listed drug Concerta.
The generic drug, manufactured by Mallinckrodt, has been found by the FDA to not be sufficiently equivalent to its referenced pioneer drug, Concerta. Generic drugs are expected to deliver the same amount of active ingredients to consumers as the pioneer drug. In this instance, the generic version does not do so. As a result, pharmacies are noticing a shortage of generic Concerta. In a press release Mallinckrodt stated that it stands by its products and believes FDA’s actions are unsupported by sound scientific evidence.
Patients, and their physicians, rely on the effectiveness of prescription drugs. Generic drugs are a cost effective option for patients. Generically speaking though, if the product does not do what the pioneer drug did, its inadequate.