Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
The Food and
Drug Administration's responsibilities continue to “outstrip” available
resources, FDA Commissioner Margaret A. Hamburg said April 23 at the
annual conference of the Food and Drug Law Institute.
“Having adequate resources remains a constant concern,” she said.
said the agency will lose $209 million this year due to sequestration.
Under sequestration, industry user fees also will remain in the Treasury
and cannot be used, she said.
Additionally, she said the majority
of FDA's budget increase in President Obama's budget request for fiscal
year 2014 comes mostly from “enhanced” industry user fees.
“Having adequate resources remains a constant concern.”
--FDA Commissioner Margaret A. Hamburg
Obama administration's FY 2014 budget proposal, released April 10,
seeks $2.6 billion in budget authority and $4.7 billion in total program
resources for FDA (70 HCDR, 4/11/13).
The overall FY 2014 request
is $821 million, or 21 percent, above the 2012 enacted level, according
to the budget proposal. Of the $821 million increase, only $52 million
is from budget authority. Industry user fees would fund 94 percent of
the proposed budget increase.
New Responsibilities Under FDASIA
said the Food and Drug Administration Safety and Innovation Act
(FDASIA) gave FDA new responsibilities, which, among others, require the
agency to speed medical product reviews and reduce drug shortages.
Under FDASIA, FDA also is required to consider patient views on treatments, Hamburg said.
She said FDA is launching a patient network website that is meant to encourage patients to share ideas.
FDA also “has nearly completed an implementation plan” for FDASIA and “you can look for that in the near future,” Hamburg said.
said the agency has seen some quality lapses in recent years that have
caused drug shortages. “Drug shortages have increased fivefold since
2006,” she said.
Hamburg said quality is a major concern for the agency, and quality depends on the companies that manufacture drugs and devices.
“Quality has to be built into products,” she said. “Quality that's built into a product prevents problems.”
said, “We've made progress in correcting and heading off drug
shortages.” She noted, however, that quality issues continue.
issues also caused the recent fungal meningitis outbreak that is linked
to 53 deaths, Hamburg said. The outbreak was caused by contaminated
drugs produced by a compounding pharmacy.
“This terrible tragedy must be a wake-up call to our nation,” she said.
said FDA recently completed a series of inspections of compounding
pharmacies and in some facilities found sterility problems and other
issues that could cause contamination. For instance, Hamburg said
inspectors found that some technicians were handling sterile products
with their bare hands.
FDA inspectors “ran into resistance” from
some compounding pharmacies, Hamburg said. “These obstacles are not new,
and this is why I've asked Congress for additional authorities.”
these new authorities, nontraditional compounding would be subject to
federal standards, Hamburg said. Traditional compounding pharmacies
typically produce a small amount of custom-made medications for
consumers who have a prescription. Nontraditional ones manufacture
without prescriptions large quantities of drugs that are sometimes
shipped over state lines.
Hamburg said under the new authorities,
nontraditional compounding pharmacies would be required to report
adverse reactions to FDA, and the agency would have clear authority to
examine their records.
Hamburg said FDA's current authorities over compounding pharmacies “are limited and lack clarity.”
“New legislation is needed to address safety concerns and to provide a more tailored approach for compounding,” she said. By Bronwyn Mixter source found here