Industry on track for 2000, PhRMA says

According to the Pharmaceutical Research and Manufacturers of America, at its annual state of the industry conference in Washington, pharmaceutical and biotechnology companies had 40 new treatments – 35 drugs and five biologics – approved by the Food and Drug Administration in 1999. The medicines target 36 diseases that affect 545 million patients and cost society an estimated $600 billion a year.

The approved medicines include two for AIDS and AIDS-related conditions, three new antibiotics, five new cancer medicines, two medicines for type 2 diabetes, two medicines for influenza and new treatments for heart arrhythmia, osteoarthritis, Parkinson's, epilepsy, ulcers, obesity and several other diseases.

"The 40 medicines approved this year bring the total for the 1990s to 370 – up from 239 the previous decade," said PhRMA's president and chief executive officer Alan F. Holmer. "And companies plan to increase investment in R&D by another $2.4 billion this year – to a record-shattering $26.4 billion. This commitment to research means that patients will have even more new medicines in the future."

The 35 drugs were reviewed and approved by the FDA in an average of 12.6 months, while the five biologics were approved in an average of 17.1 months – the tail end of the lengthy process of discovering, developing and testing medicines after many years of discovery, development and clinical trials. Holmer attributed the expeditious review times in large part to the gains made under the Food and Drug Administration Modernization Act of 1997. Under this law, companies that sponsor new drug applications pay user fees, which enables FDA to hire additional reviewers.

The projected $26.4 billion research and development investment by PhRMA member companies in 2000 represents a 10.1% increase over last year's figure. This investment is 20.3% of total U.S. sales and exports – a higher ratio of R&D to revenues than virtually any other industry in the United States.

Said Holmer, "The industry's ever-increasing investment in research, the improving efficiency of the Food and Drug Administration, the quantum leaps in science now being made and the already full pharmaceutical pipeline provide concrete hope of continuing and accelerated progress against disease." PR