The Public Has a Right to Know How Government Makes Drug Approval Decisions

The Public Has a Right to Know How Government Makes Drug Approval Decisions

Hi, I’m Jon Riches the director of national litigation
at the Goldwater Institute. Today in a major decision for healthcare
transparency in the United States the 9th Circuit Court of Appeals
ruled in favor of the Goldwater Institute in an important Freedom of
Information Act request case. In 2014, the Goldwater Institute submitted a FOIA
request to the Food and Drug Administration asking how that agency
made life-saving drugs available to two American doctors who’d been infected
with the Ebola virus in West Africa the Goldwater Institute didn’t seek
commercial information or financial information, we didn’t seek any
information about private parties. Instead we asked what government
processes and procedures were used to make a life-saving drug available during
an emergency. Rather than provide that information, the FDA argued that its own regulations prevented it from disclosing any
information about investigational drugs and all information about investigational
drugs was private commercial information. Today, the Ninth Circuit Court of Appeals
disagreed it said that the FDA’s internal regulations do not trump federal law, and
the agency cannot withhold this information unless it can demonstrate a
specific FOIA exemption. At a time when many Americans are focusing on the FDA’s
authority over medicine and healthcare this decision is a significant victory.
The FDA should be applauded for making drugs available to Americans and to
others during an emergency, but it should also make sure that the decisions it
makes about how these drugs are made available are open, so that we can
improve medical regulation, so that we can ensure innovation and availability
and prevent future health care catastrophes. You can learn more about
the case at Thank you.

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