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Prescription Drugs

As our nation’s use of prescription drugs increases, rising pharmaceutical costs and drug safety issues are posing a major challenge to America’s healthcare system.

BCBSA believes the best way to improve the affordability of prescription drugs is to assure a competitive pharmaceutical market. With prescription drug costs skyrocketing, generic drugs offer consumers a safe, equally effective and lower-cost alternative to brand-name prescriptions.

While the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) included provisions to help increase consumer access to generic drugs, additional steps are needed. BCBSA supports efforts to:

• Remove barriers to approval for generics and improve the generic drug approval process;
  
• Establish a mechanism to license comparable and interchangeable biologic products or biogenerics. Currently, the FDA lacks a clear-cut process for abbreviated approval of biogenerics, and brand-name biologic drugs are absorbing a growing proportion of healthcare resources; 
  
• Improve the Citizen Petition process so that petitions on minor issues do not needlessly delay FDA review and approval of generic versions of brand-name drugs;
  
• Bar reverse payments from brand-name manufacturers to generic manufacturers, which delay market introduction of newly approved generics; 
  
• Increase funding to the FDA Office of Generic Drugs to provide adequate staffing and assure prompt review of generic drug applications; and
  
• Ensure the availability of affordable generic alternatives in all drug classes by preventing the passage of legislation backed by branded drug manufacturers that would “carve-out” certain drug classes from state generic substitution laws.

Finally, BCBSA urges Congress to ensure that the rapid flow of drugs into the market is accompanied by adequate safety monitoring, as well as the provision of health outcomes information to protect consumers. BCBSA supports increasing FDA post-market surveillance of new drugs - in cooperation with large payers - to detect adverse events quickly and increasing FDA review of direct-to-consumer advertising to assure that inappropriate use is not promoted.

BCBSA Policy and Positions
BCBSA’s Position on Expanding Access to Generic Drugs

Other Resources
Blue Plans’ Best Practices for Promoting Generic Drugs

Coalitions
Coalition for a Competitive Pharmaceutical Market
http://www.therightprescription.org/