Reauthorization of Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA)
BPCA and PREA have changed pediatric practice because all studies result in labeling changes that provide valuable new pediatric information. These studies have resulted in new dosing information, new indications of use, new safety information, and new data on effectiveness. Drugs studied under BPCA and PREA treat a wide range of diseases in children, including cancer, HIV/AIDS, diabetes, allergy and asthma.
426 drug labels have been revised with important pediatric information (181 under PREA, 147 under BPCA, 50 under both BPCA and PREA, and 48 under precursor regulations).
Before BPCA and PREA, the vast majority of drugs—more than 80%—used in children were used off-label, without data on their safety or efficacy. Today that number has been reduced to approximately 50%. While there has been significant success, more progress is needed.
PPAG endorses the reauthorization of this important legislation. Futhermore, we believe that PREA should be made permanant law.
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Drug Shortages Prevention Act
New legislation (H.R.3839), which PPAG endorses, mandates expedited review of drugs vulnerable to shortage in order to prevent shortages in the first pace and it requires the FDA to use a more refined regulatory process that addresses manufacturing problems without instigating drug shortages. Two additional bills, S.296 entitled "Preserving Access to Life Saving Medications Act" and its companion bill, H.R.2245 "Preserving Access to Life Saving Medications Act of 2011 were introduced last year.
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ARCHIVE FILES
340B Pricing
The federal 340B drug pricing program provides access to a discounted price on outpatient prescription drugs to certain health care facilities, including hospitals serving a disproportionate share of Medicaid and uninsured patients. For many years the free standing children’s hospitals were barred from access to the 340B program because we were not included in the Public Health Service (PHS) Act. After years of working through the legislative process, children’s hospitals were finally included as 340B covered entities under the PHS Act in September of 2009 and thereby allowed to apply for covered entity status and gain access to 340B pricing.
The recent healthcare reform legislation inadvertantly exempts free-standing children's hospitals from 340B pricing. PPAG is urging Congress to correct the mistake.
For more information and to learn how you can help, click here.
LEGISLATIVE UPDATE: Congress Restores 340B Orphan Drug Discounts for Children's Hospitals!
SCHIP: State Children's Health Insurance Program
The Pediatric Pharmacy Advocacy Group believes that all children should have access to comprehensive, age-appropriate, quality health care.
Preserving the State Children's Health Insurance Program (SCHIP) is a top legislative priority for PPAG. The program provides insurance coverage to 6 million children nationwide. Millions more are eligible but not enrolled. PPAG wants SCHIP legislation that will provide adequate funding for the program, including a comprehensive benefits package. Find out more about SCHIP below:
An Overview of State Children's Health Insurance Program (HHS)
To learn how you can get involved in your community, please contact PPAG.
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