BIO Break

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  • 02/26/2006

At a recent conference of biotech executives, frustration seemed to be the order of the day with venting the inevitable result. Both are understandable. The remarks (dutifully reported by Lisa Richwine of Reuters and reprinted below) show an industry and an agency engaged in a life-or-death battle. Actually, two life-or-death battles. The first is corporate survival, the second, patient survival. And while saving lives is more important than making money (is it even necessary to say that?) you can’t have one without the other. No biotech industry, no new lives saved, extended, or enhanced.

The general frustration is the on-going dichotomy of predictability versus ambiguity at the FDA. One reviewer deals with a sponsor one way while two doors down data is addressed in an entirely different manner. Predictability is power in pursuit of the public health. And while that’s always been true, today it’s become an urgent public health imperative.

Reform is crucial. Or should I say “critical” … like in Critical Path.

Here’s the Reuter’s article. Read beyond the frustration and the venting and you’ll see an opportunity for greater collaboration between regulators and regulated. A high-wire balancing act? Certainly. But one well worth the effort.

Business as usual is not an option.

Biotechs say FDA ranges from good to ‘horrifying’
By Lisa Richwine

BOSTON (Reuters) — Biotechnology companies trying to get new drugs to the market have had experiences with U.S. regulators that range from productive to “horrifying” as they craft early development plans, senior executives told Reuters this week.

Interactions can vary vastly between Food and Drug Administration divisions that review products and provide guidance to companies long before they seek approval to sell a drug, company officials said.

“We have some very good experiences and we have had some horrifying experiences, where you wonder, ‘Where did that come from?’” Genzyme Chief Executive Henri Termeer said at the Reuters Biotechnology Summit in Boston. “What is reasonable and what is not reasonable differs by individual … It’s quite frustrating,” he added.

FDA officials have acknowledged inconsistencies, or a lack of clarity, from some reviewers during early stages, when companies are seeking input on how to design clinical studies of experimental medicines. They have pledged improvements and launched major efforts to work with manufacturers earlier in the process to help more drugs make it to the market.

The agency holds more meetings than ever with drugmakers, more than 2,000 annually.

“We believe more and better interactions will lead to better outcomes and have invested a lot of resources in these efforts,” Scott Gottlieb, FDA deputy commissioner for medical and scientific affairs, said via e-mail. The FDA also is providing guidelines on how to develop better applications, he said. Officials will announce other measures to improve the review process soon.

Biotechs can face more challenges than traditional pharmaceutical companies. Many biotechs are small, inexperienced and testing their first product. Their technology may be new and unfamiliar to regulators.

Alnylam Pharmaceuticals Inc. CEO John Maraganore said his company has had “remarkably good” dealings with the FDA on efforts to develop treatments based on a new “gene silencing” technology.

“You can engage them in a science-based discussion … People that run into troubles don” engage them in that type of dialogue,” he told the Reuters Summit.

FDA staff are very responsive on potential breakthrough drugs, said Ariad Pharmaceuticals Inc. CEO Harvey Berger. Having “fast-track” status for promising medicines helps insure regular communication, he said. His company’s employees talk often with the agency in person and on the phone and get answers to questions within days. “I think the key is you have got to have a drug that they see a real opportunity for,” Berger said.

Cell Therapeutics Inc. CEO Jim Bianco agreed FDA staff will move quickly for drugs that are “sexy,” but said less exciting, though still important, medicines can get left behind. His company has been frustrated in its development of a cancer drug, Xyotax, which he described as a traditional chemotherapy medicine with fewer side effects.

European regulators are open to clearing the drug based on evidence it is equivalent to other chemotherapy, rather than superior, because it has less toxicity, but U.S. regulators are not, Bianco said.

FDA staff “are not equipped to handle that,” he said. To the agency, “standard chemo is not what moves the field forward,” he said.

Genzyme’s Termeer said it has become easier to deal with European regulators, who routinely approve his company’s products before the FDA does.

“The Europeans are willing to delegate much more of the process … to expert opinions. Much more of the work is done outside the bureaucracy,” he said.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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