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AHF: Victory Over FDA on Gilead’s PrEP

  AHF: Victory Over FDA on Gilead’s PrEP

 A Federal Court in large part denied a Summary Judgment motion filed by the
Food and Drug Administration (FDA) against AHF and ordered the FDA to provide
 AHF with data, documents, correspondence and meeting minutes between the FDA
and Gilead Sciences related to Gilead’s new drug application (NDA) for use of
  its AIDS drug, Truvada, for pre-exposure prophylaxis (PrEP) as a form HIV
                                 prevention.

 U.S. District Judge Margaret M. Morrow upended previous stonewalling by the
   FDA and Gilead when she rejected the overwhelming majority of exemptions
        sought by the FDA and ordered it to produce numerous records.

Business Wire

WASHINGTON -- February 18, 2014

AIDS Healthcare Foundation  (AHF) won another key legal victory late last week
in a push for drug safety as well as increased government transparency when a
federal court ruled against the Food and Drug Administration (FDA) and
rejected the overwhelming majority of exemptions sought by the FDA in Freedom
of Information Act (FOIA) requests tendered by AHF regarding correspondence
between the FDA and Gilead Sciences related to Gilead’s new drug application
(NDA) for use of its blockbuster AIDS drug, Truvada, for pre-exposure
prophylaxis (PrEP) as a form HIV prevention.

In a ruling late last week, The U.S. District Court, Central District of
California issued a Judgment and Order that ordered the FDA to provide AHF
with data, documents, correspondence and meeting minutes between the FDA and
Gilead Sciences. Last August, AHF won an initial ruling in its FOIA case
against the FDA; however, the FDA claimed exemptions for many documents. At
the time, the court directed the FDA to file a Vaughn Index (a document that
agencies prepare in FOIA litigation to justify each withholding of information
under a FOIA exemption), and ordered the FDA to provide certain documents ‘in
camera’ for inspection by the court.

In her ruling last week (CV 11-07925 MMM [JEMx]), Judge Margaret M. Morrow
ordered, “That defendant FDA is ordered to produce the following records in
their entirety, except for the information that this judgment specifies can be
redacted. The documents the FDA is directed to produce are:

  *“datasets” supporting Gilead’s NDA, which pertain to its “efficacy
    analysis,”
  *“datasets” supporting Gilead’s NDA, pertaining to its “safety analysis”
  *“safety and efficacy information” and “efficacy and safety data”
  *“raw data”
  *“adherence data”
  *“study data”
  *“diagnostic results”
  *“data interpretation records”
  *“second Medguides email”
  *“meeting minutes documents.”

“Through her ruling, Judge Morrow’s completely upends FDA stonewalling by
rejecting the overwhelming majority of exemptions sought by the FDA, and by
ordering it to produce numerous records, documents, data and correspondence to
AHF,” said Michael Weinstein, AIDS Healthcare Foundation President. “We
suspected that the FDA colluded with Gilead to fast-track approval of Truvada
as PrEP regardless of the results of clinical trials. Judge Morrow’s initial
FOIA ruling last August suggested the FDA advised Gilead how to conceal
unfavorable clinical trial results and coached them on what to say to get
those unfavorable results spun in such a way that the FDA deemed them
sufficient to approve the drug. Today’s ruling is an even bigger victory for
increased government transparency, hampering the government’s ability to
withhold information about a drug’s safety and efficacy. This ruling also
brings us one step closer to finding out if our suspicions about collusion
between the FDA and Gilead were justified.”

In September 2011, AHF filed a lawsuit against the FDA over its denial of
several AHF Freedom of Information Act requests regarding correspondence
between the FDA and Gilead Sciences regarding its potential application to
expand the use of Truvada for use as a form of pre-exposure prophylaxis.
Despite concerns and complaints from AHF and other advocates and the pending
FOIA lawsuit, the FDA approved Gilead’s application for use of Truvada as PrEP
on July 16, 2012.

“The lack of neutrality shown by the FDA throughout its dealing with Gilead on
this matter is simply breathtaking—further underscored in recent years by the
fact that the FDA’s budget for drug approval is now directly paid for by
pharmaceutical companies such as Gilead,” said Tom Myers, General Counsel and
Chief of Public Affairs for AIDS Healthcare Foundation (AHF).

For more information, please visit www.aidshealth.org

About AHF

AIDS Healthcare Foundation (AHF) is the largest non-profit HIV/AIDS healthcare
provider in the USA. AHF currently provides medical care and/or services to
more than 282,000 individuals in 32 countries worldwide in the US, Africa,
Latin America/Caribbean, Eastern Europe, and Asia. Additional information is
available at www.aidshealth.org, find us on Facebook:
www.facebook.com/aidshealth and follow us on Twitter & Instagram:
@AIDSHealthcare

Contact:

AIDS Healthcare Foundation
WASHINGTON, DC:
Tom Myers, 323-860-5259 (office/cell)
General Counsel
Tom.myers@aidshealth.org
or
LOS ANGELES:
Samantha Azulay, +1-323-860-5223 (work)
Assistant General Counsel
samantha.azulay@aidshealth.org
or
LOS ANGELES:
Ged Kenslea, +1-323-308-1833 (work)
Senior Director, Communications
+1-323-791-5526 (cell)
gedk@aidshealth.org
 
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