BIO and Sanofi are pushing the FDA to tweak its drug shortage rule for vaccines

Strong demand for flu vaccines in Canada has left authorities scrambling for supplies this winter, but in general preventive vaccines have suffered less severe shortages than drugs in recent years. The Biotechnology Industry Organization (BIO) argues this is evidence the current system for vaccines works and has asked the FDA to rethink its drug shortage plans.

When the FDA was given the power to include biologics in its drug shortages program, legislators also gave it the option to exclude vaccines. The Centers for Disease Control and Prevention (CDC) already requires notification of potential supply constraints in its Vaccines for Children (VFC) contracts with manufacturers, so lawmakers were unsure whether FDA involvement was necessary. In November, the FDA confirmed it would include vaccines under the drug shortage rule, citing the need to oversee vaccines not in the VFC program--such as products for rabies, yellow fever and typhoid--as justification.

Not everyone agrees though. In feedback to the regulator, BIO argues oversight by CDC is sufficient, noting that while shortages still occur the effect on public health has been cut. And the long lead times and reliance on somewhat unpredictable biological organisms inherent to vaccine production set it apart from the manufacture of small molecule drugs. The differences are so pronounced and CDC oversight so effective that vaccines should be excluded, or at least treated differently, BIO argues. The group also claims vaccine companies are already voluntarily complying with the FDA rule.  

Sanofi ($SNY) makes similar points about voluntary compliance, the need to take vaccines' unique manufacturing requirements into account and the achievements of CDC oversight in its comments. BIO and Sanofi both call for FDA to at least limit the scope of its rule to vaccines not already covered by VFC.

- here's Regulatory Focus' take
- check out details of Canada's shortage
- read BIO's comments
- and Sanofi's feedback

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