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Author Archive for: ‘ECLawrence’

  • Drug companies re-patenting old drugs to extend price monopolies

    Drug re-patenting is making waves in the pharmaceutical market. This practice allows drug manufacturers to continue enjoying a sales monopoly while dramatically reducing research and development costs. In the 1980s, the European Patent Office (EPO) passed patent laws to protect new uses of known drugs. …

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  • Pending Circuit Court Case Could Accelerate Availability of Some Biosimilars

    Pending in the Court of Appeals for the Federal Circuit in northern California is a case involving an effort to bring a biosimilar drug to market without making use of the “biosimilars pathway” included in the Biologics Price Competition and Innovation Act (BPCIA).  Depending on …

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  • New restrictions on hydrocodone

    The federal government has issued a final rule imposing new restrictions on hydrocodone combination products (HCPs). Effective October 6th, 2014, hydrocodone-based products will be re-categorized as Schedule II drugs under the Controlled Substances Act. This higher drug classification includes highly controlled substances such as opioid …

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  • Games Drug Companies Play to Keep Drug Prices High

    Just recently, we ran across two new examples of pharmaceutical manufacturers acting counter to the interests of patients and payers.  In one case, the manufacturer of a drug losing patent protection next year decided to turn off supply of the patented drug in order to …

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  • Focus on Community Pharmacy Medicare Fraud

    A recent New York Times article, “Pervasive Medicare Fraud Proves Hard to Stop,”  states that “Fraud and systematic overcharging are estimated at roughly $60 billion, or 10 percent, of Medicare’s costs every year, but the administration recovered only about $4.3 billion last year.”  Let’s put …

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  • The openFDA initiative: a new usage standard for health care data

    On June 2, 2014, the Food and Drug Administration (FDA) launched a publicly searchable, interactive database that allows health care stakeholders easy access to the FDA’s public data. This access will include updated drug product labeling for close to 60,000 prescription and over-the-counter drugs, recall …

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  • Federal Trade Commission Weighs in on PBM Compensation Disclosure

    As we noted in an earlier piece, the ERISA Advisory Council this year is studying the issue of whether pharmacy benefit managers (PBMs) should be required to make compensation and fee disclosures to employee health plan sponsors.  On June 19, 2014, the Advisory Council held the first of …

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  • Corporate Inversions and the Prescription Drug World

    There has been a lot of news lately about increased use of a tax-saving transaction known as a “corporate inversion.”  Among the parties that have recently discussed these transactions are several U.S. pharmaceutical companies and drugstore chain Walgreens. In an inversion, a U.S. company acquires …

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  • CBO Confirms Competition Works to Reduce Medicare Part D Costs

    The Congressional Budget Office has just released a new report, “Competition and the Cost of Medicare’s Prescription Drug Program,” that details how the Medicare Part D program has successfully harnessed competitive forces to bring down prescription drug costs. First some really encouraging news.  According to …

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  • Concerns grow around new antibiotic bill and its effect on patient outcomes

    The Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT Act) (H.R. 3742)was introduced by a bipartisan group of representatives on December 12th, 2013. The purpose of the Act is to advance drug development in order to combat the serious and growing public health …

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