Thirty-Nine New Drugs Approved In 1998; Pharm R&D Increases To $24 Billion

Pharmaceutical research resulted in the approval of 30 new drugs and 9 new biologics in 1998, and companies expect to invest a record $24 billion in 1999 to discover and develop future medicines—thus ensuring that the remarkable progress against disease that has characterized the 1990s will continue into the 21st century.

R&D investments by reseasrch-based pharmaceutical companies.

The biggest increase in R&D is on the domestic side. Domestic R&D is expected to go up by nearly 17% this year, while R&D conducted abroad by U.S.-based companies will increase by about 2%. This suggests that the U.S. has a legal and regulatory environment that supports biomedical innovation and helps patients. It also suggests that other countries have policies in place that discourage innovation, to the detriment of patients.

The medicines approved by the Food and Drug Administration in 1998 address diseases affecting more than 180 million patients and costing more than $400 billion per year. Among the new treatments are:

• The first in a new class of drugs for asthma, which affects an estimated 14.6 million adults and children in the U.S. alone
• A new AIDS medicine requiring only once-daily dosing
• The first medicine specifically approved to treat Crohn's disease, a chronic and debilitating gastrointestinal disorder
• The first new tuberculosis drug in 25 years
• Three new medicines that will expand treatment choices for the 2.1 million Americans with rheumatoid arthritis
• The first in a class of drugs for Parkinson's disease, a progressive neurological disorder that affects 1.5 million Americans
• The first vaccine to prevent Lyme disease
• A breakthrough drug for erectile dysfunction
• Two important new medicines for breast cancer, which affects 1 out of every 10 American women
• The first vaccine to prevent rotavirus infection, the most common cause of severe and sometimes fatal diarrhea in children

The medicines brought to market in 1998 will save lives and raise the quality of life for millions. They also offer the potential of savings to the health care system by keeping people out of emergency rooms, hospitals and nursing homes and enabling them to stay on the job and with their families.

For example, new medicines for arthritis and Parkinson's disease can cut costly nursing home admissions, and a new medicine for respiratory syncytial virus (RSV) could prevent many of the 90,000 hospitalizations and the 4,500 deaths caused by this disease each year.

The 30 drugs were reviewed by the FDA in an average of 11.7 months, after many years of testing and development by the companies; the biologics were reviewed in an average of 13.5 months. All of the medicines approved this year benefited from user fees paid by pharmaceutical companies to enable FDA to hire additional personnel to review new drug applications. User fees have helped the FDA reduce review times, which averaged more than 30 months before the start of the user fee program. As a result, patients have access to safe and effective new treatments sooner.

In the 1990s alone, pharmaceutical companies have made 333 new medicines available to patients. These medicines have helped cut deaths from heart disease, cancer, AIDS, and many other diseases, allowing millions of people to lead longer, healthier and more productive lives. The industry's record breaking commitment to research investment—together with the hundreds of new medicines already in the pharmaceutical pipeline and the rapidly accelerating body of knowledge about how disease works—provides hope that, in the 21st century, many of today's ravaging diseases will be known only in history books.

For more information: Alan F. Holmer, president, PhRMA, 1100 Fifteenth Street, NW, Washington, DC 20005. Telephone: 202-835-3400.