FDA Hearing on Innovation and Access

Discussion Academic Perspectives Researchers and academics focused heavily on increasing competition through: reforming REMS regulations; addressing harms from citizen petitions; and brand pharmaceutical marketing practices. Michael Carrier, an expert in the pharmaceutical industry and antitrust laws at Rutgers Law, stated that certain actions by brand companies distort the Hatch-Waxman Act to evade the system and impede entry of generics to the market, and that these actions “are not about innovation.” FDA panelists were interested in how to prospectively address the approximately 20 percent of reformulations, or changes in brand product, that are aimed at elongating exclusivity. Harvard Medical School researcher Ameet Sarpatwari presented research showing that violations of REMS by brand companies restricted access to drug samples and therefore delayed generic entry. He used this data to advocate for the CREATES Act and FAST Generics Act, both of which he said would close REMS loopholes and potentially save up to $5.4 billion a year in reduced drug costs. Dr. Sarpatwari noted that in 2012, brand companies spent $24 billion marketing to physicians against generics, and $3.1 billion on marketing directly to consumers. Payer and Provider Perspectives Payers and providers expressed frustration with brand companies using FDA regulations to inhibit generic entry, including pay-for-delay, patent evergreening, and product-hopping. Todd Ebert and Wayne Russell of the He...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs