FDA chief gives promises on generics

Citing the saving of $1.67 trillion that competition from generics has brought to the US health care system in the last decade, Food and Drug Administration (FDA) Commissioner Scott Gottlieb has voiced his support for more of these copycat drugs to reach market sooner.

Dr Gottlieb pledged to help make this happen by addressing scientific and regulatory obstacles to generic competition across the full range of FDA-approved drugs through the Drug Competition Action Plan.

Writing for the FDA’s  official blog, he announced that a public meeting would take place on July 18 to gain input on where the FDA’s rules – including standards and procedures related to generic drug approvals – are “being used in ways that may create obstacles to generic access, instead of ensuring the vigorous competition Congress intended.”