Tag: drug manufacturers

Domestic Production of Pharmaceuticals: Are the Administration’s Efforts Enough?

Merle M. DeLancey, Jr. ●

The Administration issued Executive Order (“EO”) 14293: Regulatory Relief to Promote Domestic Production of Critical Medicines on May 5, 2025 (whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines). The EO seeks to ease obstacles for drug manufacturers to establish or expand domestic production facilities. For example, it streamlines Food and Drug Administration (“FDA”), Environmental Protection Agency, and Army Corps of Engineers reviews and inspections associated with building or expanding manufacturing facilities. These accelerated processes are intended to reduce a manufacturer’s cost to build or expand a facility with the intended result being lower prices for domestically produced drugs.

The EO also calls for enhanced FDA inspections of foreign manufacturing facilities. The inspections will be funded through increased fees imposed on foreign drug manufacturers. The likely result will be an increase in foreign drug production costs, which would lead to increased prices of foreign-produced drugs. Further, adding to the price of foreign drugs are the Administration’s proposed tariffs. If imposed, the tariffs could start at 15 percent and ratchet up to 150 percent and 250 percent over time.

The goal of increasing the prices of foreign-produced drugs is to enable domestically produced drugs to compete. Only time will tell whether the EO’s efforts will be enough to level the playing field. However, there are at least two obstacles that could prevent the Administration from reaching its goal.

Continue reading “Domestic Production of Pharmaceuticals: Are the Administration’s Efforts Enough?”

Biden Administration Prioritizing Domestic Production of Pharmaceuticals . . . Again?

Merle M. DeLancey, Jr. ●

On November 27, the Administration announced another blue-ribbon panel to bolster the domestic manufacturing of pharmaceuticals. This one is called the Supply Chain Resilience Council. Co-chairs of the Council are Lael Brainard, Director of the White House National Economic Council, and Jake Sullivan, the White House National Security Advisor. Among the other 25 Council members are multiple agency Secretaries; the U.S. Trade Representative; the Chair of the White House Council of Economic Advisers; and the Directors of National Intelligence, the Office of Management and Budget, and the Office of Science and Technology Policy. The Council does not include any industry representatives.

A major part of the Council’s plan to bolster domestic manufacturing is providing the Department of Health and Human Services (“HHS”) with expanded authorities under Title III of the Defense Production Act (“DPA”) to invest in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs deemed crucial for national security. HHS will be granted DPA authority beyond what it was given during the COVID pandemic.

Continue reading “Biden Administration Prioritizing Domestic Production of Pharmaceuticals . . . Again?”

Nevada Publishes 2023 Drug Price Transparency Lists

Merle M. DeLancey, Jr. ●

On January 31, 2022, the Nevada Department of Health and Human Services (“DHHS”) released its annual drug lists in accordance with its Drug Transparency Reporting Program. DHHS published four drug lists: List #1 Essential Diabetes Drug Summary List; List #2 Essential Diabetes Drug List with WAC; List #3 Essential Diabetes Drug List (with Significant Price Increase); and List #4 Over $40 Drug List (with Significant Price Increase). (Nevada Drug Transparency Drug Lists 2023)

Drug manufacturers with drugs identified on Lists #2, #3, and/or #4 are required to submit reports to the Transparency Program on or before April 1, 2023. The reporting templates and instructions can be found here: Manufacturers. Do not wait until late March to prepare the reports because the information requested is detailed and will likely require input from multiple divisions or functions within a company. Examples of the information required to be reported include: total cost of producing the drug; total administrative expenditures related to the drug; profit manufacturer earned from the drug; percentage of manufacturer’s total profit attributed to drug during marketing period for drug; and, for lists #3 and #4, an explanation for the applicable drug’s price increase.

Continue reading “Nevada Publishes 2023 Drug Price Transparency Lists”

What Could a DHHS Secretary Becerra Mean for the Pharmaceutical Industry?

Jay P. Lessler, John M. Clerici, and Merle M. DeLancey Jr.







President-elect Biden plans to nominate California Attorney General Xavier Becerra to serve as Secretary of the U.S. Department of Health and Human Services (“DHHS”). The current Administration has frustrated the pharmaceutical industry with numerous Executive Orders and proposed rules and regulations trying to impact drug pricing. DHHS’s interim final rule implementing a Most Favored Nations Model (i.e., an international pricing index) for reimbursement of certain Medicare Part B drugs is the most recent example.

Numerous pundits suggested that pharmaceutical companies manufacturing vaccines and other drugs to respond to the COVID-19 pandemic waited until after the November election to announce their progress. The rationale was that the companies would prefer working with a Biden Administration rather than suffer through four more years of acrimony with the Trump Administration. The Becerra announcement, however, could indicate the pharmaceutical industry is not yet out of the woods. Continue reading “What Could a DHHS Secretary Becerra Mean for the Pharmaceutical Industry?”

States Pass Fewer Drug Manufacturer Pricing Disclosure Laws in 2018

Merle M. DeLancey Jr.

While the introduction of state legislation that would require drug manufacturers to disclose pricing and other information did not slow down in 2018, the number of bills that were made law did slow down. During 2018, 22 state legislatures considered bills seeking to require drug manufacturers to disclose pricing information; however, most of the legislation failed.

Two New State Laws

Since my Drug Manufacturer Pricing Disclosures: Mid-Year 2018 Update, two states—Vermont and New Hampshire—passed laws that arguably touch on requiring pharmaceutical manufacturers to report drug prices.[1] Continue reading “States Pass Fewer Drug Manufacturer Pricing Disclosure Laws in 2018”

Drug Manufacturer Pricing Disclosures: Mid-Year 2018 Update

Merle M. DeLancey Jr.

Earlier this year, I commented on state drug pricing transparency laws in effect and/or enacted during 2017.[1] I also opined that it was likely more states would pass similar transparency laws requiring drug manufacturers to disclose pricing and/or price increases during 2018. While proposed drug pricing transparency and disclosure legislation has been introduced and is pending in numerous states, during the first half of 2018 only two states (Oregon and Connecticut) passed new laws imposing price disclosure requirements on drug manufacturers. Maine expanded its existing disclosure law. Also of note was the United States Court of Appeals for the Fourth Circuit finding Maryland’s Anti-Gouging law unconstitutional. Continue reading “Drug Manufacturer Pricing Disclosures: Mid-Year 2018 Update”

2017 Was a Busy Year for State Imposition of Drug Manufacturer Price Disclosure Obligations and 2018 Isn’t Looking Much Better

Merle M. Delancey Jr.

Although several bills were introduced in Congress and President Trump has complained that drug prices are way too high, during 2017, the federal government did not pass any law nor implement any policy requiring drug manufacturers to disclose information concerning price increases. As a result, state legislatures have stepped in to fill this void. Unlike Congress, state legislatures have been much more aggressive in taking on drug price increases. Continue reading “2017 Was a Busy Year for State Imposition of Drug Manufacturer Price Disclosure Obligations and 2018 Isn’t Looking Much Better”

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