Counterfeits
Counterfeiters continue to become more sophisticated, as demonstrated in the recent discovery of fake Avastin sold to doctors
in California, Texas, and Illinois. Unfortunately for patients, this "lower-priced European alternative" of Avastin has no
active ingredient (bevacizumab). FDA sent letters to 19 doctors instructing them to stop using this unapproved product and
pointing out the dangers of purchasing critical medicines from unknown sources, in this case from Quality Specialty Products
(also known as Montana Healthcare Solutions). The doctors evidently were attracted by a $1900 price tag on a drug that usually
costs about $2400 from Roche's Genentech. The Avastin incident prompted the Senate to approve a bill stiffening penalties
on drug counterfeiters, and further legislation may authorize a better drug tracking system to distinguish genuine medicines
from fakes. In addition, the Institute of Medicine is preparing a report for FDA on ways to detect and prevent drug counterfeiting
and adulteration, hoping for delivery by year-end.
Bioterrorism
Biotech manufacturers are cheering new legislation to strengthen the nation's response to public health emergencies, which
provides added support for developing new medical countermeasures critical to such efforts. The US House or Representatives
approved the Pandemic and All-Hazards Preparedness Act (PAHPA) in late 2011, and the Senate followed suit last month. The
bill authorizes about $8 billion over five years to bolster detection and response to threats by the Centers for Disease Control
and Prevention (CDC) and increases funding for countermeasure development and procurement. FDA also gets support for expert
teams to provide technical assistance to manufacturers of vaccines, treatments and diagnostic tests important for responding
to threats.
Recently issued key guidance documents
- Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic (FDA Final
Guidance)
- Size of Beads in Drug Products Labeled for Sprinkle (FDA Final Guidance)
- Q3C Impurities: Residual Solvents (FDA final recommendation based on ICH guideline)
- Drug Interaction Studies–Study Design, Data Analysis, Implications for Dozing, and Labeling Recommendations (FDA Draft Guidance)
Recent legislative proposals
- H.R. 4056, Science and Technology Regulatory Relief Act of 2012, proposed by Rep. Brian Bilbray (R-CA), would prevent states
from duplicating FDA inspections of drug or medical device manufacturers.
- S. 2113, the Transforming the Regulatory Environment to Accelerate Access to Treatments Act, or Treat Act, proposed by Sen.
Kay Hagen (D-NC), would speed new therapies for critical diseases through the FDA regulatory process.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, jwechsler@advanstar.com
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