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
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