Skip to main content
Keeping you afloat amidst the rising sea of regulations

Oregon Joins Growing Number of States with New Drug Pricing Transparency Laws

Oregon is the latest state to adopt a drug pricing transparency law, following in the footsteps of Vermont, California,

Fighting the Opioid Epidemic: New DOJ Prescription Interdiction & Litigation Task Force To Target Drug Manufacturers & Distributors

On February 27, 2018, Attorney General Jeff Sessions announced the launch of the Prescription Interdiction & Litigation Task Force (PIL Task Force), which will use criminal and civil law enforcement tools to combat the nation’s opioid epidemic, specifically targeting drug manufacturers and distributors. This is the latest development in the government’s increasing focus over the past year on the opioid epidemic.

Late Night Budget Bill Contains Provisions of Interest to Big Pharma

The Bipartisan Budget Act of 2018 was signed into law on February 9, 2018 in order to avert another shut-down of the federal government. Although the Act contains appropriations and budgetary provisions typical of such a bill, it also includes several provisions that are attracting the attention of pharmaceutical manufacturers, pharmacies, Medicare Part D Plans, and others in the industry.

PhRMA Challenges Constitutionality of California’s New Drug Pricing Transparency Law

On December 8, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a lawsuit in the US District Court for the Eastern District of California seeking to block California’s new drug transparency law. The complaint for Pharm. Research and Mfrs. of Am. v.

FDA Requires Pharma Companies to Certify Drug Listing Info

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations. The rule made some fairly substantial changes even though the rule became effective last November, and drug companies may just now start to feel the impact of some of the rule’s requirements.

340B Program Participants Take Note: New Technical Changes Are Coming

On September 5, 2017, the Health Resources and Services Administration announced the transition to a new Office of Pharmacy Affairs Information System (340B OPAIS), which will impact and modernize the current 340B covered entity database and will also impact the mechanism through which drug manufacturers report 340B drug prices to HRSA. To educate both covered entities and drug manufacturers about the details of the new 340B OPAIS, the Office of Pharmacy Affairs will be conducting two public webinars later this month.

Sweeping Nevada Law to Impact Manufacturers, PBMs, Pharma Sales Representatives, and Nonprofit Organizations

Nevada is the latest state in the Union to adopt some form of a drug pricing transparency law, after Nevada Governor Brian Sandoval signed Senate Bill No. 539 into law on June 15, 2017. The breadth and scope of this particular bill is unlike any other transparency bill that we have seen to date, and has the potential to impact not only the manufacturers of the narrow class of drugs the bill focuses on, but all manufacturers with sales forces in Nevada, as well as non-profit patient assistance programs.

Pharma Industry Take Note: Maryland Passed Price-Gouging Prohibition

Alleged price gouging by drug manufacturers and distributors has been in the news the past several years, causing many lawmakers to threaten to take action. Maryland has become the first state to do so – on May 26, 2017, Governor Larry Hogan of Maryland informed the Maryland Speaker of the House that he would permit H.B. 631, also known as the “Prohibition Against Price Gouging for Essential Off-Patent or Generic Drugs”(437th Gen. Assemb., Reg. Sess. (Md.

Reminder to Generic Manufacturers: Q1 2017 Unit Rebate Amounts Billed by State Medicaid Programs Will NOT Include Additional Discounts

Pursuant to the Bipartisan Budget Act of 2015, manufacturers participating in the Medicaid Drug Rebate Program must pay an Additional Discount on Non-Innovator products to the extent the Average Manufacturer Prices (“AMPs”) of their products are rising faster than inflation when compared to a base line period.