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Getting drugs made can be harder than creating them

Street Smarts. By Scott Gottlieb, MD, amednews contributor. Jan. 14, 2002.

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STREET SMARTS

A column looking at the corporate side of health care

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Since May 2001, patients prescribed the monoclonal antibody Enbrel have carried a special card, verifying for their pharmacist that they are eligible to receive the medicine.

Sounds like a page out of a methadone clinic, right?

These tight checks, however, aren't performed because Enbrel is a controlled narcotic. The drug is part of a revolutionary new class of compounds that must be specially crafted with mammalian cell cultures. The drug's creator, Seattle-based biotechnology company Immunex Corp. simply cannot make enough of it.

Was it poor planning, or the result of a flood or a fire on the Immunex production line? No. As badly as the company wants to bring more manufacturing space on line, it has been hobbled by a morass of FDA regulations that stretch months into years and prevent them from building new plants.

Because most small companies can't risk investing in a $300 million to $500 million manufacturing site years before their drugs pass regulatory muster, there are few facilities coming anytime soon. Contract manufacturers with outsourced production plants are full, and biotech companies with their own facilities are running at capacity. The result is a worldwide shortage in manufacturing space for monoclonal antibodies and long waiting lists for Enbrel.

Americans want safeguards built into the process by which drugs and vaccines are manufactured. But the process for certifying new manufacturing space has become so Byzantine that it now takes a year to build a plant, then three years to get it inspected and approved. [...]