Wyeth
In October 2005, Wyeth filed a Citizen’s Petition “seeking FDA actions
to counter flagrant violations of the law by pharmacies compounding
‘Bio-identical Hormone Replacement Therapy’ (BHRT) that endanger
public health.” IACP quickly mobilized its team to respond and
correct the erroneous and misleading statements in Wyeth’s Citizen’s
Petition. If Wyeth’s petition influenced the FDA, results would be
cataclysmic for many compounders. If successful, Wyeth’s petition
would essentially eliminate the ability to prescribe BHRT. Initially,
IACP prepared a legal brief as well as media and trade press releases
highlighting the errors, inaccuracies and flaws in the petition. In its response
to the petition, IACP highlighted the following points to the FDA:
• Wyeth ignored the role of the prescribing physician, who initiates
the prescription for a compounded medication, and is a central
component of the patient-physician-pharmacist “triad” relationship.
• Wyeth erroneously asserted that compounding pharmacies are
manufacturers, and should be required to comply with Good
Manufacturing Practices (GMPs) and other manufacturer
requirements.
• IACP pointed out that compounding pharmacists are not
preparing copies of commercially available preparations, as alleged
by Wyeth. Wyeth claims both that pharmacies are copying
commercial products and that its products, by nature, are unable
to be copied. Wyeth can’t have it both ways.
• IACP also disputed Wyeth’s allegation that promotional materials
distributed by compounding pharmacies makes those pharmacies
into manufacturers. A pharmacy that makes improper claims is
simply a pharmacy that is out of compliance and existing regulatory
structures are equipped to address complaints of noncompliance.
Noncompliance does not suddenly change a pharmacy’s identity
and convert them into a manufacturer, subject to the laws and
regulations applicable to manufacturers
IACP led the effort for the mobilization of patients, pharmacists, physicians
and other health care professionals to tell the FDA about their positive,
in some instances life changing, experiences with BHRT. IACP’s efforts
included providing sample letters for patients/physicians/pharmacists and
facilitating contact with the FDA. Thanks to the many IACP members who
made significant contributions to this campaign!
quoted from IACP 2005 Report