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Commentary

Hot Topic: Political Virus
Wall Street Journal, 10-22-05

The Journal chronicles how the government has killed the goose that laid the vaccine golden-egg. Over the last few decades, price controls and liability-exposure, combined with onerous and expanded regulations at the FDA, have crippled the vaccine industry

Even now, facing the possibility of a global pandemic, politicians are on the verge of inflicting yet more damage on the industry and its ability to produce the medicines we desperately need.

The U.S. today has only three large vaccine makers--down from 37 in the 1960s. This is the reason that, as recently as 2001, there was a shortage of eight of 11 critical childhood vaccines. It is also the reason the U.S. fell drastically short of flu vaccine a year ago, after a shut-down of one of two major flu-vaccine makers. And it is the reason only one company, Switzerland's Roche, is being counted on for a drug that would potentially protect against bird flu.
Despite these warning signals, Washington has done almost nothing. One problem is the Food and Drug Administration, which puts safety above developing rapid cures. Flu-vaccine makers face particular difficulties because they must effectively gain approval for a new product (for each new flu strain) every year. The vaccine is still grown in chicken eggs--a process that takes up to eight months. The industry has revolutionary new technologies--reverse genetics and mammalian cell culture--that would dramatically reduce the time and cost of development. Europe is moving toward products using these new techniques, but the FDA refuses to adapt and allow more rapid approval.
The feds have also done their best to remove any financial incentive--i.e., profit--for developing new vaccines. The Vaccines For Children program, a pet project of Hillary Clinton back in her First Lady days, has been especially destructive. The program now buys more than 50% of all private vaccines, and it uses this monopsony clout to drive prices down to commodity levels. …

Decades of price controls and letting plaintiff’s lawyers treat the vaccine industry like an ATM can’t be undone overnight. But focused reforms—streamlining and modernizing FDA regulations, lifting price caps and a broader liability shield—would be a great start.



Project FDA.
  
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