Thirteen antibiotics are awaiting approval for marketing by the Food and Drug Administration and 10 are in the final stages of clinical trials, according to a survey by the Pharmaceutical Research and Manufacturers of America.
In addition, five other antibiotics are in various stages of development, the Washington-based industry trade group said. PhRMA represents more than 100 pharmaceutical companies.
The survey results are evidence that drugmakers haven't dropped the ball on the development of antibiotics, as some critics contend, the trade group believes.
Infectious-disease experts are predicting a crisis ahead for the U.S. healthcare system. They say more bacteria are acquiring resistance to the drugs that once vanquished them, and there aren't enough new antibiotics forthcoming (June 13, p. 47). Inadequate infection control and widespread antibiotic usage have encouraged resistance to antibiotics.
Drug companies have antibiotics lined up that can tackle some of the bacteria becoming more resistant, such as pneumococci and enterococci, PhRMA said.
Both bacteria flourish in the hospital environment and are major causes of hospital-acquired infections, such as urinary tract infections. Enterococci strains now cause about 12% of the 1 million to 2 million infections acquired in hospitals each year.
Some 19,000 people die each year because of hospital-acquired infections, and the direct medical cost of such infections was $4.5 billion in 1992.
Altogether, 79 drugs-including the antibiotics-are in development to treat infectious diseases other than AIDS, PhRMA said. However, 32 of those drugs already have received FDA approval, so physicians may be prescribing them now in off-label uses. PhRMA didn't have a breakdown of how many of these FDA-approved drugs are antibiotics.
There are 103 drugs in testing for AIDS and related infections.
Since 1960, drug companies have developed 53 antibiotics, PhRMA said. Nearly two-thirds of those received FDA approval after 1980.
Several companies are experimenting with new technologies that could make antibiotics more powerful, PhRMA said. Those include substances that inhibit the enzyme making some bacteria-resistant. Others are using a process called "anti-sense technology," which can block genetic messages vital to the disease process.