Regulatory and Washington

It’s been an interesting year for the generics industry. While the volume of dispensed prescriptions rose, the Food and Drug Administration, under a new commissioner, has taken several steps that certainly will impact the industry in the short and long terms. Drug Store News sat down with Chester “Chip” Davis, president and CEO of the Association for Accessible Medicines, to discuss how the generics industry is adapting to a changing market, and new opportunities manufacturers may be looking to pursue.

Despite the challenges that manufacturers have faced from slowing generics spending growth, generics saved the U.S. healthcare system more than ever, and the past year has seen a record number of approvals. It also has seen more biosimilars getting regulatory approval, and the Food and Drug Administration carving out new and speedier paths for companies to enter areas where there is a market need for the products.

BERKELEY, Calif. — Dynavax Technologies last week announced that the U.S. Food and Drug Administration has approved Heplisav-B for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. Heplisav-B is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults.

WASHINGTON — A former pharmaceutical industry executive who also served in the Dept. of Health and Human Services under President George W. Bush has been nominated to lead the department. President Donald Trump on Monday named Alex Azar as his pick for secretary of health and human services.

Truth 7: Regulations no excuse for poor branding

Regulation, varying from country to country, affects many substantive aspects of what constitutes OTC branding and what is allowed in packaging design, claims, evidencing, marketing communications and sampling. And it changes all the time, with very little chance of any form of regional harmonization any time soon, let alone global.

WASHINGTON — The dietary supplement industry’s leading trade associations and the U.S. Anti-Doping Agency on Wednesday joined in support of the U.S. Food and Drug Administration’s recent actions to protect consumers from body-building products containing Selective Androgen Receptor Modulators (SARMs) illegally marketed as dietary supplements.

BETHESDA, Md. — For the more than 30 million people in the U.S. with diabetes, the director of the National Institute of Diabetes and Digestive and Kidney Diseases division of the National Institutes of Health urged people to eat better as part of a best practice in taking care of their condition.