PhRMA: 32 new drugs were available in 2001

April 1, 2002

Pharmaceutical Representative

In 2001, pharmaceutical and biotechnology companies made 32 new treatments – 24 drugs and eight biologics - available to consumers, according to the Pharmaceutical Research and Manufacturers of America.

In 2001, pharmaceutical and biotechnology companies made 32 new treatments – 24 drugs and eight biologics - available to consumers, according to the Washington-based Pharmaceutical Research and Manufacturers of America.

Though PhRMA President Alan F. Holmer was happy with the new treatments, he said the industry still needs to make sure the drugs get to the right people. "As we continue to bring newer and better medicines to patients, it underscores the need to enact a prescription drug benefit for America's seniors this year," Holmer said. "It can be done, it should be done. It's the number-one priority for the industry this year."

The medicines the industry made available in 2001 will treat or prevent 32 diseases, which together cost society more than $250 billion a year in other healthcare costs, as well as lost productivity and wages, according to PhRMA. In 2001, PhRMA member companies invested an estimated $30.3 billion in research and development – a 16.6% increase over the 2000 figure.

The new drugs approved by the Food and Drug Administration in 2001 include innovative treatments for AIDS, arthritis, cancer, glaucoma, heart disease, infectious diseases, schizophrenia, Alzheimer's, migraine headaches and other diseases.

"Patients and their families will benefit from the industry's innovation, and so will the healthcare system," said Holmer.

Approval times

The 24 drugs approved in 2001 were reviewed by the FDA in an average of 16.4 months, and the eight biologics were reviewed in an average of 19.6 months. This represents a slight improvement over 2000, but approval times for both drugs and biologics in 1999 and 1998 were somewhat shorter.

"The increases in review times since 1998 and 1999 are a disappointment to the industry and patients," Holmer noted. "We plan to work with the FDA and Congress in addressing the issue of review times in the context of the Prescription Drug User Fee Act. Getting safe and effective medicines to patients promptly is far too important to permit the loss of momentum that the agency established through 1998 and 1999." User fees paid by pharmaceutical companies under PDUFA pay the salaries of the 900 FDA reviewers and help ensure that medicines get reviewed in a timely manner.

"The 32 medicines made available this year and the industry's continuing commitment to research will add up to better health for patients, now and in the future," said Holmer. "Our dedication to the search for new cures has never been stronger." PR

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