Transcript Crafting Bipartisan Policies to Minimize Drug Shortages

Crafting Bipartisan Policies to Minimize
Drug Shortages
Nancy E. Dunlap, MD, PhD, MBA
2011-2012 RWJF Health Policy Fellow
Committee on Energy and Commerce
US House of Representatives
Guess the weight and win a prize!
Drug Shortages are Increasing
250
200
• # Drugs
150
100
50
0
2005 2006
2007 2008
2009 2010
2011
Latest Drug Shortage Threatens
Children With Leukemia
by Richard Knox
Stakeholders
• Generic Manufacturers
• Pharmaceutical Co.
• Patient Advocacy
• Group Purchasing Org.
• Professional Societies
• Pharmacies
• FDA
• Hospitals
• DEA
• Distributors
What actions have been taken?
• ASPE: Economic analysis of causes
• FDA and industry: Examining root causes
• Executive order: Improved reporting
What can Congress do to help?
• Does FDA need new authority?
• Do we understand the drivers of the supply
chain?
• What does industry and the FDA need to do
differently?
Current Law: SEC. 506C.
Discontinuance of a Lifesaving Product
(a) IN GENERAL.—A manufacturer that is the sole manufacturer of a drug—
• (1) that is—
– (A) life-supporting;
– (B) life-sustaining; or
– (C) intended for use in the prevention of a debilitating disease or
condition;
•
(2) for which an application has been approved under section 505(b) or 505(j); and
•
(3) that is not a product that was originally derived from human tissue and was replaced by a recombinant
product, shall notify
the Secretary of a discontinuance of the
manufacture of the drug at least 6 months prior to the date of the
discontinuance.
Democrats and Republicans agree on the
end result.
The differences are in how to get there!
What issues needed resolution?
• What drugs need to be reported to the FDA?
• What does the FDA need to do differently?
• How do you enforce industry participation?
• How do you avoid release of proprietary
information?
Positions
• Democrats
• Republicans
• More Information
• Essential Information
• More FDA Authority
• More Industry Incentive
• Orderly Planning
• Expedited Applications
Imbalance of Power
The Power of the Press
News
Report: Fight Over FDA User Bills
Threatening To Derail Legislation
By Alexander Gaffney 25 April 2012
TITLE IX—DRUG SHORTAGES
• Clarify definitions of reportable drugs
• Define timeframe and data reported to FDA
• Insure confidentiality
• Define consequences if fail to report
TITLE IX—Continued
• Establish drug shortage list
• Encourage FDA expedited review
• Commission GAO study to identify causes
• Report annually on Drug Shortages
– HHS and DEA
"No one in this world, so far as I know, has ever lost money by
underestimating the intelligence of the great masses of the plain
people."
-H. L. Mencken
Bipartisan FDA User Fee Bill Breezes
Through House Panel
By Brett Norman May 8, 2012
After …“intense negotiations as recently as last weekend,”
…, the committee …passed the bill by unanimous voice
vote
…But the markup couldn’t have been more cordial...
Waxman said development of this bill “should be a model
for legislative action,” and heads nodded, all around.
Proposed Timeline
• HELP Committee– April 2012
• Energy and Commerce Committee– May 2012
• House– May/ June 2012
• Senate– May/June 2012
• Possible Conference Committee– June 2012
• President– July 2012
Points of Difference
House vs Senate Versions
• Definitions of reportable drug
– Sterile injectable drugs/ Biological Products
• Consequences if fail to report
– Enforcement action or Warning Letter
• Study Scope and Task Force
Addendum
• “Since reaching out to industry, there has been a
six-fold increase in early notifications from
manufacturers. We have been able to prevent
128 drug shortages…”
– Commissioner Margaret Hamburg, May 4, 2012