Katy Koski

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For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug manufacturers and the U.S. Department of Health and Human Services (HHS).…
With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public availability of these medications.  In March 2015, for instance, Congress investigated “price hikes” by Amphastar Pharmaceuticals, Inc. (“Amphastar”) for naloxone (sold under the brand name Narcan®), a generic prescription medicine that blocks the effects of opioids and reverses an overdose.  Ranking Members of the House Committee on…
Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue: EpiPen’s classification as a generic drug for purposes of the Medicaid Drug Rebate Program (“MDRP”).  Resolution of the classification issue carries significant risk for segments of the drug industry.…
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic refusal of “innovator” companies to (1) share drug samples needed for generic and biosimilar regulatory testing and…
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic refusal of “innovator” companies to (1) share drug samples needed for generic and biosimilar regulatory testing and…
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of affordable generic drugs” and biosimilar products. The bill, entitled the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2016, S. 3056, would punish the strategic refusal of “innovator” companies to (1) share drug samples needed for generic and biosimilar regulatory testing and…
Growth in health care costs has long been a source of political and administrative tension for public health agencies across the country. More and more, health officials, legislators, patient advocacy groups, and third-party payors blame budgetary constraints and patient dissatisfaction and poor outcomes on high prices for once affordable medications. The issue of drug pricing has generated intense interest among federal regulators, the Department of Justice, Congress, and now, state legislatures.…
The first quarter of 2016 has witnessed a great deal of attention in government to the problem of opioid-related overdose and death in the United States. In just the past few weeks, the Senate passed prescription drug treatment and abuse prevention legislation—the Federal Comprehensive Addiction and Recovery Act (CARA), Senate Bill 524—while two states—Massachusetts and Wisconsin—enacted legislation establishing new rules and procedures for the prescribing, use, and disposal of controlled substances. The Centers for…
Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading” statements about off-label uses for its omega-3 drug, Vascepa, violated Amarin’s right to engage in constitutionally protected speech. The underlying claims and settlement may have important implications for how drug makers market and sell their products going forward.…
The U.S. Food and Drug Administration (“FDA”) recently announced a “far-reaching action plan” to evaluate and improve the agency’s prescription opioid policies. The announcement came amidst public criticism and mounting political pressure on the FDA to address the country’s “opioid abuse epidemic,” including a hold placed by Senate Democrat Edward J. Markey on President Obama’s nominee to lead the FDA, Dr. Robert M. Califf. In a December 21, 2015 letter to U.S. Department of…