Category: Legislative

Legislative

Legislative

FDA Shares Drug Review Priorities, Sets Date for Public Meeting

FDA Shares Drug Review Priorities, Sets Date for Public Meeting

Sept. 10, 2021 – The Food and Drug Administration (FDA) recently issued a commitment letter regarding the next iteration of the Prescription Drug User Fee Act (PDUFA VII) that spells out its review timeframes, performance goals and modernization priorities for fiscal years (FYs) 2023-2027. Among these priorities are enhancements related to expediting drug development, expanding decision […]

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Legislative

What Biden’s Drug Pricing Plans Could Mean for Biopharma

What Biden’s Drug Pricing Plans Could Mean for Biopharma

Aug. 16, 2021 – As part of his “Build Back Better” agenda, President Joe Biden re-emphasized in a televised address last week that he would like Congress to make changes that would allow Medicare to negotiate drug prices to reduce costs for “millions of Americans.” Specifically, Biden wants to see legislative reforms that would remove […]

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Legislative

21st Century Cures 2.0 Seeks to Formalize Plans for ARPA-H

21st Century Cures 2.0 Seeks to Formalize Plans for ARPA-H

July 6, 2021 – The authors of the 21st Century Cures Act, which passed with bipartisan support in 2015, now want to build on its success with new legislation that would improve clinical trials, provide information and training for patients and caregivers, and fund President Joe Biden’s concept for an Advanced Research Projects Agency for […]

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Legislative

Maryland Legislature Overrides Gov. Hogan Veto, Enacts Digital Advertising Tax

Maryland Legislature Overrides Gov. Hogan Veto, Enacts Digital Advertising Tax

Feb. 15, 2021 – The Maryland House and Senate voted last week to override Gov. Larry Hogan’s May 2020 veto and enact the nation’s first tax on digital advertising, a move that other states are in the process of considering in light of a backlash against big tech companies and significant budget shortfalls as the […]

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Legislative

Pharma Reputation on the Line During COVID-19 Crisis

Pharma Reputation on the Line During COVID-19 Crisis

June 29, 2020 – After being scrutinized for years regarding drug pricing issues, the biopharma industry is enjoying a boost in public opinion during the COVID-19 crisis. However, that boost may slowly be fading as lawmakers and the public continue to be skeptical of the industry, as evidenced by two bills introduced in the House […]

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Legislative

Gov. Hogan Vetoes Maryland Digital Ad Tax Legislation

Gov. Hogan Vetoes Maryland Digital Ad Tax Legislation

May 11, 2020 – A bill that proposed a Maryland tax on “digital advertising services” that was approved by the state legislature in March was vetoed on May 7 by Maryland Gov. Larry Hogan (R), stopping, at least for now, the nation’s first tax on digital advertising. In his veto letter, Hogan stated that the […]

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Legislative

CHC Endorses Request Calling for Veto of Maryland Tax on Digital Advertising

CHC Endorses Request Calling for Veto of Maryland Tax on Digital Advertising

April 6, 2020 – The Coalition for Healthcare Communication last week endorsed an urgent request to Maryland Governor Larry Hogan (R) to veto HB 732, which would put in place the nation’s first tax on digital advertising. The request, sent March 31 by national media and advertising trade associations and members of The Advertising Coalition, […]

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Legislative

Emergency Relief Package Yields Increased FDA Funding, OTC Revisions

Emergency Relief Package Yields Increased FDA Funding, OTC Revisions

March 30, 2020 – In addition to providing millions of Americans and many industries with financial support during the coronavirus outbreak, the emergency relief bill passed by Congress and signed into law by President Donald Trump on Friday accrues additional funding for the Food and Drug Administration’s coronavirus efforts and makes important changes to how […]

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Legislative

Senators Push New Bill to Require Drug List Prices in Ads After Regulation Set Aside by Court

Senators Push New Bill to Require Drug List Prices in Ads After Regulation Set Aside by Court

Nov. 11, 2019 – As Congress works to agree on legislation that would rein in drug prices, a bill co-sponsored by Sen. Charles Grassley (R-Iowa) and Sen. Dick Durbin (D-Ill.) – which would require that list prices be included in direct-to-consumer (DTC) television advertisements – may be close to a vote. Grassley and Durbin hoped […]

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Legislative

Drug Marketing Not Addressed – Yet – in House or Senate Drug Pricing Proposals

Drug Marketing Not Addressed – Yet – in House or Senate Drug Pricing Proposals

Sept. 20, 2019 – Although the House proposal unveiled by House Speaker Nancy Pelosi (D-Calif.) to combat high drug prices would cap Medicare drug prices based on the average price in six developed countries, require that the federal government and drug companies negotiate prices for up to 250 of the most expensive prescription drugs, mandate […]

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