NCPA - National Center for Policy Analysis


March 28, 2007

Modern pharmaceuticals have never been safer, more effective, more innovative -- or more stringently regulated. But that seems to have escaped the notice of many members of Congress. Various senators have introduced two separate bills that will further obstruct innovation and threaten public health, says Henry I. Miller, a fellow at Stanford University's Hoover Institution.

  • Sens. Edward Kennedy (D-Mass.) and Michael Enzi (R-Wyo.) proposed legislation to grant the Food and Drug Administration (FDA) new authority to impose safety requirements on medicines after their approval for marketing and would also would require registration of clinical trials and the reporting of their results in public databases.
  • Sens. Chris Dodd (D-Conn.) and Charles Grassley (R-Iowa) introduced legislation to create within the FDA a center to oversee the safety of drugs after they go on the market.

These bills will discourage drug development by making it more difficult and expensive and less profitable. This at a time when an aging American population desperately needs new and improved (and cheaper) medicines, and when pharmaceutical R&D is already ailing.

The trends are ominous:

  • The length of clinical testing for the average drug is increasing, fewer drugs are approved and the number of industry applications to FDA for marketing approval has been declining for more than a decade.
  • Unsurprisingly, in the last 20 years, development costs skyrocketed, with direct and indirect expenses now exceeding $900 million to bring an average drug to market.

Not surprisingly, those costs have been passed along:

  • This month, the AARP reported a 6.2 percent rise in the manufacturer list price for 193 brand-name prescription drugs and 75 generic prescription drugs commonly used by adults aged 50 and older.
  • That's almost double the nation's overall inflation rate of 3.2 percent in 2006.

Source: Henry I. Miller, "Golden goose of medicine," Washington Times, March 28, 2007.


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