New Questions on Safety - Pharmaceutical Executive

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New Questions on Safety
Vioxx, vaccines, and SSRIs: Today's bad news as tomorrow's agenda.


Pharmaceutical Executive


The debacle spotlighted serious problems with the US vaccine supply system. Only two other manufacturers produce flu vaccine for the huge US market, a situation that limits how officials can respond to emergencies. Critics regularly propose that the federal government take over US vaccine distribution and production, and this latest incident is unlikely to encourage private sector investment without added incentives and liability reform.

The Chiron crisis may spark interest in proposals to spur more flu vaccine production, including those that would:

  • "expand government purchase guarantees to cover unused doses.
  • "provide grants and support for manufacturers adopting modern production techniques. NIH officials are offering up to $150 million in financial incentives to encourage pharma companies to develop modern flu vaccine production technologies such as cell-based cultures and DNA engineering. Everyone agrees that it's vital to shift away from today's old-fashioned egg-based systems, but that could take years.
  • "expand vaccine production through regulatory and market reforms. A report from the National Vaccine Advisory Committee, which appeared in October as the flu vaccine crisis was emerging, recommends dropping price caps on vaccines for children, improving vaccine coverage by payers and insurers, and seeking more harmonization in US and foreign vaccine approval requirements to increase supplies in an emergency.

Jill Wechsler is Pharmaceutical Executive's Washington correspondent.


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