Safety Concerns Downfall for New Drugs [Reuters]
<<The FDA will more closely scrutinize the safety record of drugs that will not significantly improve upon the treatment options already available for a particular disorder, Temple [FDA] said. This makes it more difficult to gain approval for a so-called ``me too'' drug if there are lingering safety questions about it.>>
Another story on the FDA raising increased safety concerns. SEPR gets a prominent mention. I imagine SEPR is none too happy with the whole concept of the "me too" drug: it's kind of their stock-in-trade. I remember that a prominent article in The New York Times laid heavy emphasis on it, implying that they were essentially fraudulent attempts to get around patent expirations.
I don't agree with that, but The Times obviously has huge influence, and I wonder if that idea has been a heavy weight on SEPR.
Doc
September 08, 2002 09:58:00 AM ET
By Jed Seltzer
NEW YORK (Reuters) - Stumbles out of the starting block are hurting drug companies aiming to get new drugs approved -- even when they think they've almost crossed the finish line.
Drug developers, confident they have cleared early clinical hurdles to get new drugs approved, are finding they can't hide from regulators poking around for skeletons in the closet.
After spending millions of dollars to conduct large late-stage tests of experimental medicines, the discovery of earlier stumbles is preventing some drug companies from bringing products to market.
The setbacks are contributing to a slump in the drug industry, where companies are spending more and more to get new product approvals and meeting with less success. Stocks of large drugmakers have hit multi-year lows and many biotechnology companies are running out of cash to develop new drugs.
With genetic discoveries aiding the understanding of the human body and specific side effects increasingly being linked to certain types of medicine, U.S. regulators can now scrutinize experimental drugs with a careful microscope.
Recently, biotechnology company Sepracor Inc. (SEPR) suffered a major blow when the FDA asked it to conduct more clinical trials on its allergy drug Soltara, the most important medicine in its pipeline. The experimental drug is among a class of drugs known as antihistamines that have been associated with a condition called ``QT prolongation'' that can lead to irregular heart beats and other complications.
The company said in March that two of the three issues raised by the FDA related to safety risks observed in animals but not seen in human clinical trials, and the third issue was QT prolongation, indicating regulators were not convinced Soltara had shed the heart concerns linked to antihistamines.
DRUGS PINPOINTED FOR LIKELY RISKS
Drug industry observers say biotechnology companies desperate for a product approval often obscure potential safety risks and don't address them head-on, but some also suggest the FDA has become more cautious in clearing new drugs.
``The FDA is becoming more conservative given the recent incidence of product withdrawals,'' said Mary Jo Veverka, a partner at consulting firm Accenture and a former deputy commissioner of the FDA.
High-profile product recalls or withdrawals in the past few years include diet drug fen-phen, diabetes drug Rezulin and irritable bowel syndrome treatment Lotronex, all pulled for major safety concerns. Some analysts believe those problems have made the FDA gun-shy about approving new medicines.
And even if a new drug demonstrates a solid safety record and adequate efficacy, regulators sometimes request additional testing if it is part of a class of drugs known to carry certain safety risks -- a setback that could delay a drug from reaching the market for years.
``And the FDA has better science and better tools, so if they understand the safety signals with a particular product, they will look for those signals with a product in the same class,'' Veverka said.
The FDA is looking more closely into certain issues because the scientific community now understands them better and can pinpoint certain drugs that may carry those safety risks, said Dr. Robert Temple, the director of one of the FDA's five offices of new drug evaluation.
He cited QT prolongation as one of a few areas where the agency can prevent future problems by asking drug companies to look specifically at the potential risk in clinical trials -- possibly asking for new tests if the agency is not satisfied.
``There are certain areas where we have learned a lot -- such as repolarization, QT interval, and interaction between drugs -- so we certainly pay much more attention to those areas than we did 15 years ago. But in most other matters, I don't think our standards are different,'' said Temple, whose office is responsible for evaluating new cancer, heart and neurological drugs.
Impatient Wall Street investors have criticized the agency for being too conservative in approving new medicines and too slow in fully replying to applications to market drugs. It also draws criticism for raising concerns only after a company has devoted years of research and resources into developing drugs.
COMMON GROUND FOR FDA, COMPANIES?
But FDA officials say the agency replies as promptly as possible after thoroughly reviewing the information.
The FDA will more closely scrutinize the safety record of drugs that will not significantly improve upon the treatment options already available for a particular disorder, Temple said. This makes it more difficult to gain approval for a so-called ``me too'' drug if there are lingering safety questions about it.
And companies do not give their complete animal data to regulators until they have submitted an application for approval of the drug. The animal tests can reveal additional hurdles that a drug will need to overcome.
Johnson & Johnson (JNJ) and its smaller partner Alkermes Inc. (ALKS) said in early July the FDA rejected their request to market an injectable version of J&J's lucrative schizophrenia treatment Risperdal, sending Alkermes' stock plunging 68 percent. An analyst report at the time cited an increased risk of cancer found in testing of the drug in rodents -- even though the drug survived three phases of clinical trials in humans without raising a significant cancer concern.
Despite the pitfalls, companies do have a recourse -- or at least a way of setting appropriate expectations.
Drug developers must quickly identify any possible setback as soon as it arises in clinical trials or even if it seems like a logical safety risk given the way a drug works, clinical testing experts said.
``If you can anticipate what would be the Achilles heal of a drug instead of being afraid to ask that question, if you just load up a program that addresses that right away, you can begin to improve your chances of working on something that has a better probability of being successful,'' said Anthony Clemento, vice president for scientific and regulatory consulting at Covance Inc. (CVD), which provides clinical testing and consulting for drug companies.
``And if it's not, the sooner you know that and you can stop and move on to something else, the better,'' Clemento said.
Drug developers should meet with FDA officials as often as possible and bring up any potential side effect problem, said Louise Shibley, vice president for regulatory and technical services at Quintiles Transnational Corp. (QTRN), which conducts drug testing, offers consulting and provides health care market information.
``It's advisable to work as closely with the agency as you can,'' Shibley said. ``It's always encouraged to keep lines of communication open with the FDA.''
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