FDA Proposes Dangerous Vaccine Rule Change

NVIC Vaccine News

by Barbara Loe Fisher

This past spring, the FDA took a hands-off approach to Merck's admission that DNA from a lethal pig virus is contaminating doses of RotaTeq vaccine being swallowed by millions of newborn babies. Now the agency responsible for making sure pharmaceutical products do not hurt people is proposing a Rule Change to give one staff employee the sole authority to allow "exceptions or alternatives" when drug companies want to change vaccine ingredients, such as preservatives (like thimerosal) or adjuvants (like aluminum) or the amount of residual protein and antibiotics in vaccines.

June 28 Deadline for Public Comment

The FDA's proposed change to Requirements for Constituent Materials was quietly published in The Federal Register on March 30 and the deadline for public comment is only days away - on Monday, June 28.

The FDA is arguing that the rule change is necessary to "reduce burdens on industry" and to provide "greater flexibility and reduced regulatory requirements." It gives one FDA staff Director the power to give drug companies the green light to "employ advances in science and technology as they become available" when companies want to make new vaccines really fast and get more bang for the buck.

Will There Be ANY Checks & Balances?

If the proposed Rule Change is put into effect, a vaccine manufacturer could request a change in the content or amount of vaccine ingredients by simply writing a "brief statement describing the basis for the request and supporting data" as part of the original license application or for a pending or approved application. There is no information about how much scientific evidence the drug companies will have to submit to prove the new ingredients are safe; or whether the FDA's Vaccine Advisory Committee will be able to review that evidence; or whether the American public will have a chance to comment before vaccine ingredients are changed.

This does not look like the transparency, public participation and collaboration in government that President Obama said he supports. It removes the checks and balances necessary for good government.

Could Warehoused Squalene Be Quickly Approved?

Last year when federal health officials declared a pandemic H1N1 "swine flu" national emergency, drug companies put a full court press on the FDA to fast track licensure of highly reactive oil based squalene adjuvants and the use of new technology, like insect cells, to make pandemic influenza vaccines. During meetings of the FDA's Vaccine Advisory Committee, the National Vaccine Information Center opposed both the quick licensure of squalene adjuvants, which hyperstimulate the immune system and have been associated with autoimmunity, and the use of insect cells, which could be contaminated with insect viruses.

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