All Articles In 'FDA Regulation'
Compounded Drugs: Congress Takes an Interest in Growing Compound Drug Industry
Compounded drugs are a new hot issue in the pharmaceuticals industry and in Congress. There are little data about compounding pharmacies, but a new Congressional Research Service brief gives a comprehensive overview. Compounded Drugs Personalize Drug [...]
Patenting Human DNA: SCOTUS Pharma and Biotech Case Preview
Patents form the basis of the pharma and biotech industry, also called the life sciences industry. They give companies an incentive to make large investments in risky drug development and innovations, which have the potential to be ineffective or to [...]
State Tort Liability for Generic Prescription Drugs: SCOTUS Pharma and Biotech Case Previews
Generic drugs have operated under a different set of rules than brand-name drugs since 1984, when Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, or Hatch-Waxman Act. Brand-name drug manufacturers must [...]
Legality of Pay for Delay Settlements: SCOTUS Pharma and Biotech Case Preview
The 2012 Supreme Court got a lot of attention for its decision to uphold most of the Affordable Care Act (ACA) health reform law in NFIB v. Sebelius. But this year’s court docket will be no [...]
Medicare Part D Spending: Key Drivers of Reduced Drug Benefit Costs
When Congress enacted the Medicare Modernization Act of 2003 (MMA), it set a spending target of about $400 billion over 10 years for the Medicare Part D drug benefit, after accounting for revenues from premiums and [...]
Patient Safety in Pharmacies: Toolkit to Improve Pharmacy Quality
Health care quality and patient safety have become increasingly important in recent years, particularly as part of efforts to prevent wasteful spending, hospital readmissions, and medical errors. Accountable Care Organizations (ACO), health information technology (HIT), electronic [...]
Prescription Drug Pricing: Estimating Generic Drug Cost Savings
Prescription drug spending rose by $135 billion between 2001 and 2010 to comprise approximately 12 percent of the nation’s overall healthcare outlay. While drug expenditure was one of the fastest growing components of U.S. healthcare spending [...]
Direct-to-Consumer Advertising of Prescription Drugs: Legal, Policy, Market, and Public Health Issues for Potential Bans on DTC Advertising of New Brand Drugs
Direct-to-Consumer (DTC) advertising of prescription drugs, especially new brand-named drugs, remains controversial. Some in Congress remain eager to prohibit advertising of brand-name prescription drugs to consumers in the first two years following a drug’s approval by [...]
American Health and Drug Benefits: March – April 2010 Issue
The latest issue of the journal American Health & Drug Benefits includes a valuable mix of studies and articles on economic, regulatory, and clinical issues of particular interest to payors, purchasers, and policymakers. Obesity: Effective Treatment [...]
American Health and Drug Benefits: September – October 2009 Issue
Here are articles from the latest issue of American Health & Drug Benefits. AHDB is a peer-reviewed journal for 30,000 decision makers in health plans, PBMs, Medicare, Medicaid, and the pharma and biotech industries: Predictive and [...]
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