FDA denied: Drug development down as companies face steeper regulations

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The prognosis for the approval of innovative new drugs is more dismal than ever.

That’s the conclusion of a study by BIO and BioMedTracker that examined over 4,000 drugs and reviewed the rate at which these new medicines were successfully brought to market between 2004 and 2010. For those drugs that progress from early stage Phase I clinical trials, the FDA currently only approves about one in ten. This is a significant drop from an approval rate of about one in five or six reported in years past. Biologics — a class of medicines comprised of proteins or antibodies derived from organisms rather than synthesized from chemicals per formula — had a 15 percent chance of going from Phase I to FDA approval versus only 7 percent for small molecule chemical drugs. Overall, infectious disease drugs had the highest success rate at 12 percent while cancer drugs came in last with only 4.7 percent of medications advancing to FDA approval.

The recent obstacles to new drug approval arise from problems generated outside the realm of research and development, says ACSH’s Dr. Gilbert Ross. “Drug development has slowed because of regulatory concerns. Pharmaceutical companies and researchers are facing tighter governmental guidelines, and when faced with that kind of uncertainty, you can’t blame them for withdrawing from drug development instead of being proactive and taking chances.”

While 80 percent of drugs eventually gain approval after making it all the way to Phase III testing — the final stage of human testing — only about half are approved on their initial FDA review. This is a statistic that, according to ACSH’s Dr. Josh Bloom, is worrisome. “It should be only the occasional drug that doesn’t get approved after Phase III trial, not nearly half of them. The historical figure for final approval after Phase III was about 75 percent. Requiring drug companies to run extra trials following Phase III is not only incredibly expensive, but also eats into the patent life of the drug, often making it unprofitable to develop at all.”

Drug makers are hesitant to invest large sums of money into new drug development since the FDA has erred on the side of precaution. “Those at the FDA responsible for approving a new drug have decided that it’s probably safer to deny a potential new medication even though it could stand to improve the lives of tens of thousands of people rather than approve it and have some unanticipated side effect lead to activist and Congressional inquiries,” notes Dr. Ross.

Speaking of hurdles in the path to new drug development, the Obama administration proposed yesterday cutting patent rights for brand-name biologic drugs from 12 to seven years as part of its 2012 budget proposal.

Dr. Bloom adds: “At a time when the administration is worried about the slow pace of drug approvals, it seems to be doing everything in its power to accelerate the process of outsourcing research and development to Asia, a trend that began about five years ago. Soon, there will be little or no research actually being done in the U.S.”

Though the new regulation may aid in reducing the national deficit, it will certainly have the potential to harm consumers since generic copy-cat biologic drugs are not as easily characterized or as identical to their original formulation. “Unlike drugs with a specific chemical formula, which are easier to develop, biologics are much more complex to manufacture,” says Dr. Ross. “This new proposal will only further deter pharmaceutical companies from aggressively pursuing new drug development, and the American public will suffer for it. The worst thing is, we don’t know how many life-saving drugs weren’t approved due to the agency’s excess of precaution.”