Zeroing in on CRADAs for drug price regulation

WASHINGTON - Members of Congress have wasted little time signalling their intent to consider regulation of prices for drugs developed with the aid of federal resources.

Pharmaceutical cost containment measures mentioned at last week's hearing on "The Pricing of Drugs Co-Developed by Federal Laboratories and Private Companies" included granting the National Institutes of Health power to regulate prices of drugs developed with federal funds, imposition of price restrictions on orphan drugs, and regulations requiring pharmaceutical companies to grant government greater access to proprietary data in order to determine drug development and marketing costs.

Rep. Ron Wyden, D-Ore., chair of the subcommittee on regulation, business opportunities and energy of the House Committee on Small Business, said that "up to half of the most valuable cancer and AIDS drugs are developed with substantial taxpayer support. American consumers who have funded drug development through the gift of corporate tax credits and federal lab research should not be bludgeoned by price gouging."

'Reasonable' profits

Wyden called for rules that would accelerate government-supported blockbuster drugs to market quickly while "allowing the companies to make a reasonable profit." He outlined several options for regulating prices of drugs developed with government funds.