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Peter Pitts in the San Francisco Business Times
Peter Pitts in the San Francisco Business Times
San Francisco Business Times
By Daniel S. Levine
Jan 26,2007
Despite growing investment in research and development, the pharmaceutical industry in 2006 continued to win approvals for new drugs at an anemic pace.
A tally of data on the U.S. Food and Drug Administration's web site found the agency last year approved a total of 19 "new molecular entities" -- drugs with a different molecular structure than any previously approved, not including biologics.
The total bested the 18 new drugs that won approval in 2005, but continues to hover around the lowest levels in recent years. The low number of new drugs highlights concerns that the massive investments in research and development is not translating into innovative new products. By comparison, the FDA approved 35 new molecular entities in 1999.
"There is a lot more work that needs to be done to clinical development both with respect to safety and efficacy issues," said Alan Goldhammer, deputy vice president for regulatory affairs for the Pharmaceutical Research and Manufacturers of America, an industry trade group. "One thing we've noticed is the number of drugs in clinical development has been increasing. We'd be far more concerned if we saw a leveling off of new compounds entering the clinic."
A November report on new drug development from the Government Accountability Office found that industry research and development grew to $40 billion in 2004, up from $16 billion in 1993, a 147 percent increase. But during that same time, the number of new drug applications for new molecular entities grew by only 7 percent.
It also found the number of new molecular entities approved since 1996 has generally declined year to year. It said that corresponds with a decline in submissions.
"These submission trends indicate that the productivity of research and development investments has declined," the report said.
The GAO cited several possible reasons for the decline, including difficulties scientists have had translating new discoveries into safe and effective drugs, uncertainty over regulatory standards for determining when a drug should be approved, and conflicting pressures on pharmaceutical companies to both avoid risk and produce a high return on investment.
But some industry representatives caution that drug development requires a long time and that investments made today would not reflect in productivity until years from now.
"We don't know yet how productive that investment has been," said Sara Radcliffe, vice president of science and regulatory affairs for the Biotechnology Industry Organization. Radcliffe also noted that new molecular entities may not offer a complete picture of innovation and productivity since often it is new uses for an already approved drug that provide important benefits to patients.
For instance, the most notable drug approvals for Bay Area companies in 2006 include: Gilead's Atripla, a combination of three existing HIV drugs into a single, once-a-day pill; and Exubera, an inhaled insulin developed by Nektar Therapeutics in collaboration with Pfizer. Neither of those products are considered new molecular entities.
Radcliffe said the industry, however, is concerned about the growing cost of drug development and points to the FDA's Critical Path initiative as a way the agency is working with industry to address that problem and accelerate the drug development process.
The Critical Path initiative is focusing on several areas, including the use of validated biomarkers -- biological surrogates to measure the safety and efficacy of drug candidates -- and new tools for drug development to go with the new knowledge that has resulted from the mapping of the human genome.
"If you are really skilled, you can build a watch with a hammer and a screwdriver, but it's really a lot better if you have more precise tools. You can do it quicker and more efficiently," said Peter Pitts, a former associate commissioner of the FDA and director of Center for Medicine in the Public Interest, a think-tank backed in part by the pharmaceutical industry. "That's what's required to lower the cost of drug development and raise the success rate."
PhRMA's Goldhammer said drug development will remain a risky enterprise for the foreseeable future, but that it is apparent that change is needed.
"Nobody believes we can continue to do business the way we do business today," he said. "There needs to be a transformation." |
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