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Drug Companies Pay FDA and NIH Pays Universities to Fast Track and Market Vaccines

vaccine approval process

Story at-a-glance -

  • In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA) to accelerate FDA licensing approvals of new drugs and vaccines. More than half of the FDA’s budget is now funded by the pharmaceutical industry through PDUFA fees
  • The Food and Drug Administration Amendments Act of 2007 allows companies developing treatment for neglected or rare pediatric diseases to pay the FDA for a priority review voucher (PRV) to fast-track approval of the drug or vaccine
  • The PRV has proved to be a windfall for companies producing vaccines. A PRV typically secures fast-track approval in six rather than 10 months
  • Under the law, drug companies developing treatments for neglected and rare pediatric diseases can sell their PRVs to other companies, including vaccine manufacturers, for millions of dollars to fast-track licensure of completely different, profitable drugs and vaccines, including the HPV vaccine
  • The federal government helps the drug industry to market more vaccines. A grant to Emory University for $767,107 for fiscal year 2017 targets pregnant women and their children for vaccination using sophisticated sales and marketing techniques

By The Vaccine Reaction Staff

When it comes to cozy business relationships between government and industry, there is nothing like the lucrative one that Congress has encouraged federal health agencies to create with the drug and vaccine industry. One hand washes the other.

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