Congressional Bill would Mandate Pass-Through of Pharmacy Price Concessions under Medicare Part D

Since November of 2017, when CMS’s announced plans to issue regulations that would require Part D plan sponsors to pass-through price concessions to beneficiaries at the pharmacy point-of-sale, discussion about a pass-through mandate has taken center stage in the drug pricing reform debate.  Such price concessions would take the form of manufacturer rebates as well […]

Trump Administration’s Drug Pricing Reforms Target Manufacturer Drug Rebates

On May 11, 2018, the Trump Administration released its long-awaited slate of drug pricing reform proposals with the publication of its “American Patients First – Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.”  The Blueprint offers a wide array of proposals designed to reduce list prices and patient cost-sharing burdens through increased competition and […]

State Drug Pricing Reforms Target Drug Copay Coupons

In early October, the California issued a new state law (A.B. 265) restricting the use of drug copay coupons.  Although the measure has received less attention than California’s highly publicized drug transparency law, which was passed on the same day, it may be a harbinger of an important new type of state drug pricing reform.  […]

California Drug Price Transparency Law Raises Hopes and Eyebrows

California recently became the third, and most prominent, state to enact a drug price transparency law.  The state has asserted itself at the forefront of drug pricing reform movement and many expect a wave of other states to follow suit with similar transparency measures. The transparency legislation (S.B. 17), which was signed by Governor Jerry […]

California Legislature Considers New Drug Price Transparency Measure

In recent years, the California legislature has emerged as a laboratory for drug pricing reform—an issue that has gripped the nation in the face of rising drug costs.  In 2015, California instituted legislation capping copayments for outpatient prescription drugs offered by commercial insurers.  However, in 2016, two drug price transparency bills were derailed and state […]

Cherokee Nation Sues Distributors and Pharmacies for Fallout from Opioid Epidemic

The Attorney General for the Cherokee Nation has filed a lawsuit in tribal court claiming that six of the nation’s top drug distributors and pharmacies have negligently or knowingly promoted the opioid epidemic that has ravaged the Cherokee Nation in Oklahoma. The lawsuit, which is the first to be asserted by an Indian nation against […]

The Government’s Evolving Enforcement Policy Regarding Distributors in the War against Prescription Opioid Abuse

Most prescribers and pharmacists are generally aware of the legal risks associated with the over-prescribing and dispensing of narcotics.  In the face of a growing national crisis, many state and federal prosecutors have begun to crack down on “pill mills” and rogue prescribers who are complicit in schemes to profit from prescription drug abuse.  While […]

FDA-Registered Outsourcing Facilities Hampered by Conflicting State Laws

With the passage of the Drug Quality and Security Act (DQSA) in 2013, the FDA introduced a new federal regulatory scheme governing outsourcing facilities registered under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). The federal government has sought to treat outsourcing facilities as distinct from pharmacies engaged in traditional compounding, which […]

Charges against Former Valeant, Philidor Executives Highlight DOJ’s Emphasis on Individual Corporate Accountability

Valeant Pharmaceuticals, Inc., the former darling of Wall Street, has suffered a dramatic reversal of fortune in the past year.  After reaching stratospheric heights, the company’s stock price plunged soon after it was targeted in October of 2015 by short-sellers who pointed to a suspicious arrangement between the drug manufacturer and an obscure mail order […]

The Populist Influence on Drug Pricing Reform

In the immediate wake of the 2016 presidential election, drug companies experienced a surge of optimism that was supported by an uptick in their stock prices.  With Donald Trump’s surprise victory, the widely-accepted view is that the pharmaceutical industry has dodged major reform and stands to benefit from the incoming administration’s apparent embrace of big business.  But while Trump did not emphasize drug […]