Excerpt from Generation Rx by Greg Critser, plus links to reviews, author biography & more

But Haddad's biggest beef with the industry — and the FDA — had provoked little in the way of action. By 1982 there was still no workable economic method for getting a generic drug approved even after a patent ran out. That was because the FDA still required any maker of a generic version of a brand-name drug to undertake the same lengthy, costly, and sometimes dangerous series of clinical trials to prove its product was safe and efficacious. Technically, this process was totally unnecessary. Time-proven methods of reverse engineering, along with sophisticated ways of assaying copycat compounds, could assure that any generic was biologically equivalent. "It was totally immoral to insist that the generic maker do all that again," Haddad argued. "But they don't care . . . they don't care about the senior citizens, they don't care about the poor single mother, they don't care . . ." Many inside the FDA agreed, but the political power of the PMA, along with institutional inertia, cowardice, and plain old bureaucratic ass- covering had precluded any meaningful reform.

Then, in mid-1982, just as the PMA and Engman were using a new, ostensibly "independent" study to convince Congress that patent life had been dramatically shortened by FDA red tape, Haddad got a letter from a woman in Florida, a statistician who claimed she had been an author of the supposedly independent study. "She said that not only had the numbers for the study been prepared for her by the industry, but that the brand names had paid for the study and then insisted that it be presented as 'independent.'" Haddad used the disclosure to stir up discontented seniors in two Miami Beach districts, who in turn "drove their congressman crazy" about why patent restoration was wrong, not to mention political suicide. Using Haddad's activism to mobilize opposition votes and Al Gore's willingness to vilify the industry in general, Waxman defeated Engman's patent-extension legislation.

For a time following his defeat, Engman worked on a number of other industry-relief efforts. Certainly the time was still right for anything that offered a way to make the nation more competitive. Congress had passed the Bayh-Dole Act in 1981, which made it easier for the industry to use research discoveries that originated in publicly funded laboratories. For pharma, that opened up a wide range of lucrative partnerships with researchers at the National Institutes of Health (NIH), where scientists were making breakthroughs in developing new molecules that could treat everything from heart disease to depression. The law also made it possible for government researchers to accept consulting fees from pharmaceutical companies. This opening-up process — in essence doing away with old church-state separations that favored institutional or scientific independence over commerce of almost any kind — was the subject of a lengthy inquiry from some of the nation's leading experts in pharmacology and drug regulation, who were joined by Engman. Commenced in the late 1970s under Tulane University's Dr. Gilbert McMahon, the Commission on the Federal Drug Approval Process was originally created as an evenhanded, fact-finding mission to discern whether many of the industry's complaints about the FDA were justified. Under Reagan, it essentially became an industry organ, funded not by the government but — under the guise of budgetary efficiency — by private interests and philanthropists in tune with the president's deregulatory impulses. As a result, the commission's official discussions about opening up the FDA took place off the record and out of media view at a Virginia resort owned by a friend of the president.

By the time the commission presented its report in late 1982, almost every discordant (i.e., anti–brand name) note had been tuned out. Instead, what Congress heard was a venerable choir of scientific voices demanding that the FDA cut the red tape and speed up approvals. The commission then presented Congress with its list of recommendations, many of which would eventually make it into the law books. Instead of requiring extensive, multiple studies for approval, the commission asked that "effectiveness should be found to have been demonstrated either by two — or, when appropriate, one — adequately designed and well-controlled studies." Foreign studies should also be admissible and given equal weight with domestic studies, even if the populations were different. The commission also advised lifting stodgy old conflict-of-interest restrictions that barred the use of industry-paid experts in FDA advisory committee meetings. Lastly, "the FDA should provide guidance to its staff to encourage all review personnel to conduct timely, forthright, and evenhanded discussions with sponsors that arise at any time during the review process."

Copyright © 2005 by Greg Critser. Reprinted by permission of Houghton Mifflin Company.