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

The statement registered in establishment realms, a further worry to pharma, when, in 1978, a number of influential medical journals began to consider banning prescription drug ads in their pages. As Steve Conafay, then a lobbyist for Pfizer, recalls, "There was definitely the feeling that the industry was under attack and that something big had to be done." Donald Rumsfeld, then the CEO of G. D. Searle, Inc., makers of a wide variety of drugs and chemicals, summed up the general attitude when, upon greeting FDA Commissioner Donald Kennedy, he "sat down across from me," recalls Kennedy, "slumped a little, and said, 'What are we doing wrong?'"

With Reaganism ascendant, the question quickly turned into: What is the government doing wrong? For Engman, now ensconced in PMA's head office, the question should have been: What can I wring out of the new political reality — Reagan's pronounced antiregulatory bent — that will directly benefit my membership, the nation's brand-name drug makers? Certainly many of his members were clamoring for a preemptive strike, with several advocating an assault on the FDA and its much hated efficacy requirements. (Congress had passed a law in 1962, known as the Kefauver Amendments, changing the Food and Drug Act and mandating that makers of new drugs prove not just that their products were safe, but that they actually worked.) The chief of research at Pfizer, then as now one of the more politically active pharmaceutical companies, had been railing against the efficacy rules for years, saying they got in the way of delivering good new drugs.

But Engman didn't think that way. He wasn't interested in deregulation for deregulation's sake. Perhaps it was that consumer bug, or perhaps it was his heady experience as leader of an agency that served "the public." Whatever the exact source of Engman's reservations, his eventual choice of legislative priorities finally came down to one issue: patent restoration. The subject had bubbled under the surface of FDA-industry relations for years. Simply put, the industry believed that the FDA was eating up the length of its patents, and profits, because of its slowness in processing new drug applications. Companies with a new discovery had to file for a patent as soon as possible, to establish ownership of the idea, but then had to wait years for approval. By the time the drug was approved, the company might have as little as half the original seventeen years of patent life usually guaranteed to innovators. That led to higher prices, longer waits for new drugs, and a general disincentive to invest in new medications. It was true that the studies proving the case for patent restoration — for laws that would give pharma additional compensatory patent time — were weak and inconclusive, but the essence of the industry argument struck a nerve with Engman: here again was a case of overregulation hurting the economy of the nation and depriving the consumer of an improved product.

What should Engman's PMA do? Sometime during the fall of 1980, he got an idea. He would use his old political contacts to shepherd legislation to extend pharmaceutical patents, adding up to seven years of exclusive marketing time for new drugs that had taken too long to get through the FDA approval process.

For a while, all of the old Engman magic seemed to work. He circulated studies showing exactly how industry suffered from FDA bureaucracy — and how few new important drugs made it through the system. He lined up experts from leading medical schools to testify on the subject before Congress. By late 1982, he had managed to push the political process as well. A bill extending patent life was passed by the Senate and referred to the House for an expedited vote.

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