Sorry About That Vaccine
Gottlieb, Scott
SORRY ABOUT THAT VACCINE BY SCOTT GOTTLIEB S ince May, patients prescribed the wonderful drug Enbrel for rheumatoid arthritis have toted around a special card, to verify for their pharmacist...
...Since 1999, it has been given an everexpanding list of required changes for the FDA to validate the plant.The high cost of regulatory compliance is one reason some major pharmaceutical companies have left the vaccine business altogether...
...Regulatory rules on vaccine production are also getting in the way of preparations for a hypothetical smallpox attack...
...Ramping up production in a bona fide crisis is no small task...
...Scott Gottlieb is a resident in internal medicine at Mount Sinai Hospital in New York and editor of the Gilder Biotech Report...
...Secretary Thompson has received proposals from ten companies, all of which will have to prove quickly that they can redirect staff, equipment and facilities...
...The need to expand manufacturing space was the cover story when Health and Human Services Secretary Tommy Thompson threatened to go to Congress to seek a generic version of the Anthrax-killing antibiotic Cipro...
...There were already large stores of Cipro on the shelves...
...Similar issues are stalling the manufacture of an FDA-approved vaccine for anthrax, manufactured by Michiganbased BioPort...
...They can do it quicklymwhen they need to...
...The future looks grim...
...Over-regulation of pharmaceutical manufacturing drives up the cost of new medicines and keeps others off the production lines altogether...
...And why this season there will be a shortage of flu vaccine...
...Inspectors don't show up on time.At each of dozens of regulatory pauses, biotechnology companies must stop and bring in FDA inspection teams, who take weeks or even months to come on site...
...Americans want safeguards built into the process by which drugs and vaccines are manufactured...
...Consider Bayer's response to mushrooming Cipro demand: converting a facility that formerly produced Baycol, a cholesterol-lowering drug that (ironically) was withdrawn by the FDA last month for an "unusually high" number of side effects...
...Genzyme Transgenics, Viragen and CropTech are transferring human genes into~ respectively~goats, chickens and tobacco plants, in order to produce protein drugs more efficiently...
...The government plans to rush inspection of new vaccine production lines, but it still will take almost a year...
...In the case of monoclonal antibodies like Enbrel, more than 200 companies are involved in developing approximately twice that number of antibodies, to treat a variety of human diseases.When other blockbuster drugs such as Enbrel or NeupogenmAmgen's new drug to help cancer patients fight infection--are added to those figures, it is clear the production crunch is just beginning...
...But the pitch was believable, and the public bought it...
...Poor planning...
...They don't want cockroaches crawling around the fermentation vats...
...The result is a worldwide shortage in manufacturing space for monoclonal antibodies and long waiting lists for Enbrel...
...Sounds like a methadone clinic, right...
...None of these.As badly as the company wants to bring more manufacturing space on line, they have been hobbled by a morass of FDA regulations that stretch months into years.And because most small companies like Immunex can't risk investing in a $300 million manufacturing site years before their drugs pass regulatory muster, there are few facilities coming online anytime soon...
...In that case, the threat was mostly to strong-arm Bayer into lowering the drug's price...
...SORRY ABOUT THAT VACCINE BY SCOTT GOTTLIEB S ince May, patients prescribed the wonderful drug Enbrel for rheumatoid arthritis have toted around a special card, to verify for their pharmacist that they were eligible to receive the newly-approved medicine...
...One reason is that calling the FDA is more akin to calling the phone i iii ii iiiii Dr...
...The drug's creator, Seattlebased Immunex, simply cannot make enough of it...
...company than the fire department...
...We're lucky...
...BioPort has not been as lucky...
...A fire on the Immunex production line...
...If the inspection process were not so slow and expensive, companies would be likelier to mothball spare production lines, anticipating future demand.And Washington might find the necessary capacity the next time we have an unexpected problem...
...But if demand suddenly takes off, even those facilities may not be enough to match demand...
...The company continues a seven-year struggle with regulators to maintain manufacturing compliance, failing for everything from fans that are too small to a bug found on a laboratory floor...
...One bit of good news is that regulatory strictures have created new industries from scratch.Whole slates of companies, for example, specialize in the outsourced production of these drugs, fleeing research-intensive companies from the risk of anticipating demand for experimental drugs that may not be approved...
...In this case-with the watch~l eye of the Secretary fixed on their hides--FDA regulators have said they can do the approvals in months, instead of the usual years...
...The FDA is crashing-inspecting the new line, but ramped-up production will still take several months...
...It upgraded its anthrax-vaccine manufacturing space a half-dozen times...
...These tight checks, however, aren't performed because Enbrel is a controlled narcotic or an experimental new medicine.The drug is a monoclonal antibody, part of a revolutionary new class of compounds that must be specially crafted with designer bacteria...
...The old Baycol facility has been turned into a Cipro factory...
...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...
...Some manufacturers have been forced to bet the farm-literally--on an alternative manufacturing method called transgenics...
...Even the Canadians fretted that they didn't have enough antibiotic stashed away to respond to doomsday scenarios...
...28 THE AMERICAN SPECTATOR 9 NOVEMBER/DECEMBER 2001...
Vol. 34 • November 2001 • No. 8
