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

"That last one was the one that really mattered, long-term," says Jonah Shacknai, then a commission staff member and now the president of Millennium Pharmaceuticals. "The real importance of the recommendations was a closer relationship between FDA and manufacturers. It used to be a solid Chinese wall. Now it had good windows in it."

But "good windows" into a regulatory agency were not what Lew Engman had in mind. He had patent reform in mind. True, there was now a little bit of obsession at work — "he could get very wound up about it" — yet as he listened to Waxman and Haddad talk, there were also other legitimate pinpricks on his conscience. What if Haddad was right? What if the PMA was on the wrong side of history? After all, in a recent district court ruling, Bolar v. Roche, a Brooklyn judge had ruled that it was not an infringement of a patent if a generics maker used a patented drug for experimental purposes in preparation for a regulatory hearing. That meant that more generics were inevitable. It would become known as the Bolar exemption.

There was also troubling momentum on the Hill. Waxman had introduced new legislation that would make it easier for generics to get approval — and with no provision for patent term restoration for the brand- name companies at all. Waxman had, in fact, shifted the entire debate. Now the "greedy" ones were the brand-name companies — something he repeated with nauseating regularity any time the media tuned in. And there was the quintessential Engman worry: Was the PMA's opposition to a faster generics process — an abbreviated new drug application (ANDA) — not all that different from the FTC countenancing the Civil Aviation Board's coziness with industry? Weren't all those FDA regulations requiring duplicate testing another form of overregulation that hurt the economy and the consumer?

What if Haddad was morally right?

Slowly, Engman started to talk about the whole issue differently, recalls Bob Smith, one of his closer staff aides at the PMA. "The companies are basically using human testing to protect the pill patents," he recalls Engman saying one day. It wasn't the first time anyone had put it quite that way, but it was the first time the head of the PMA had, or at least the first time one had done so out loud. Not long after, Engman assigned his lead counsel to begin negotiations with Haddad andWaxman's staff to cut a deal: the PMA would trade its opposition to generics for a guarantee of patent term restoration. A deal was struck with Waxman's staff. It included the Bolar exemption, thus putting into the law books what had only recently been rendered by a district court. Generic companies could now use formerly protected brand-name compounds to develop their low-price alternatives.

Immediately, a small but loud group of pharma CEOs called for Engman to abandon the deal. "I thought Lew had gone out of his tree," says Irwin Lerner, then the head of Hoffmann- LaRoche, which made Valium. "He was embarrassed by it, I could tell. But he was also arrogant about it. He wasn't going to back off the deal. His attitude was, 'Who the hell are these guys around the table telling me what to do?' He thought he was still the head of the FTC."

"All of the sudden, these guys who had been for the deal started freaking out," recalls Bob Smith. "All of a sudden, everyone had an exception — What about my Valium? What about my Inderal? They were all afraid that one company would get an advantage the other would not. Lew wasn't totally surprised by it, but he was determined to live up to his deal with Waxman."

Joe Williams, then the chairman of the PMA board and the head of Parke-Davis, was furious. He asked for Engman's resignation. The man in the arena was fired.

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