The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    Senate Committee Advances OTC Monograph Reform Bill

    The Senate Health, Education, Labor and Pensions Committee on Thursday advanced a bill by voice vote that would reform the way over-the-counter (OTC) drugs are brought to market by creating a user fee system like the ones used for prescription drugs and devices. The bill, introduced by Sens. Johnny Isakson (R-GA), who’s resigning from the Senate at the end of the year, and Bob Casey (D-PA), aims to speed up the antiquated approval process for OTC drugs and would create ...
  • Regulatory NewsRegulatory News

    Senate Coalesces Around Series of Drug Pricing Bills With Little Impact on Pharma Companies

    The Senate Judiciary Committee on Thursday advanced four bills to the Senate floor, three of which were bipartisan, and all meant to lower the prices of prescription drugs. The four bills are part of a coordinated push in the Senate and include a larger bill that advanced Wednesday out of the Senate health committee and is expected to be taken up on the Senate floor before the end of July, and another bill that Sen. Chuck Grassley (R-IA) said he was likely to advance ...
  • Regulatory NewsRegulatory News

    Foreign Threats to NIH Research: Senate Finance Committee Digs In

    China, Russia and Iran were singled out in a Senate Finance Committee hearing on Wednesday as countries that are looking to either undermine or usurp scientific research conducted with US taxpayer funds. Committee Chairman Chuck Grassley (R-IA) made clear that China is “by far the most prolific offender,” offering the example of attempts by Chinese researchers to steal genetically modified corn seeds in Iowa and send them back to China. “Researchers who are secretly ...
  • Regulatory NewsRegulatory News

    HHS Secretary Nominee: 'No Silver Bullet' to Bring Down Drug Prices

    President Donald Trump's Department of Health and Human Services (HHS) Secretary nominee Alex Azar told the Senate Finance Committee on Tuesday that drug prices "are too high" and he will work to bring them down, though, "There's no silver bullet." Azar previously told the Senate Health, Education, Labor and Pensions Committee that drug prices will be his top priority. The comments on Tuesday followed questions raised by Sen. Ron Wyden (D-OR) and others regardi...
  • Regulatory NewsRegulatory News

    Updated: House and Senate Pass Tax Overhaul

    The US House of Representatives and the Senate on Wednesday passed the GOP tax overhaul bill. President Donald Trump indicated he will sign the bill into a law. Bill Details Members of the House-Senate Conference Committee on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half . The cut would reduce the credits claimed by companies by $32.5 billion from 2018 to 2027, according t...
  • Regulatory NewsRegulatory News

    Senate Tax Plan Seeks to Reform, Rather Than Repeal, Orphan Drug Tax Credit

    The Senate’s tax plan, running counter to the House’s call to eliminate the orphan drug tax credit for research on drugs to treat rare diseases, seeks to modify the credit instead. The proposal would limit what level of expenses will qualify and limit qualified clinical expenses if they are related to the use of a drug which has previously been approved for diseases or conditions affecting more than 200,000 persons in the US. The tax credit is part of a law from...
  • Regulatory NewsRegulatory News

    Many Questions, Few Answers in Senate Hearing on Opaque US Drug Pricing System

    The Senate Health, Education, Labor & Pensions (HELP) committee on Tuesday discussed with representatives of the pharmaceutical supply chain how the drug delivery system affects what patients pay. Although none of the comments and arguments for reducing the price of pharmaceuticals were new, panelists and senators even seemed to disagree on what exactly is causing prices in the US to be so much higher than the rest of the world. Mark Merritt, president of the Phar...
  • Regulatory NewsRegulatory News

    Senate Passes 'Right-to-Try' Bill

    The Senate on Thursday passed via unanimous consent (meaning there was not actually a vote) a bill that claims to improve terminal patients' access to experimental drugs but, if passed in the House and signed into law, may further burden and undermine the US Food and Drug Administration (FDA). The bill is part of what's known as the "Right-to-Try" movement, which has been sweeping across state legislatures  (37 states now have such laws), and is part of a bid to in...
  • Regulatory NewsRegulatory News

    Senate Committee Takes First Step on Rising Pharmaceutical Prices

    The US Senate Health, Education, Labor and Pensions Committee held the first of three hearings on rising pharmaceutical prices Tuesday, discussing the confusing system by which prices are set and possible ways to bring them down. Sen. Lamar Alexander (R-TN) opened the hearing by highlighting the extent to which biopharmaceutical companies pay for the development of new medicines, and to note there will be two more hearings focused on R&D and supply chain expenses, ...
  • Regulatory NewsRegulatory News

    Senate to Take on Pharmaceutical Prices Again: Real Reform or More of the Same?

    The Senate Health, Education, Labor & Pensions (HELP) committee will hold a hearing Tuesday on prescription drug costs and look to address a problem many in America are grappling with: how the drug delivery system affects what patients pay. The hearing will likely address how pharmacy benefit managers (PBMs), insurers and others in the prescription drug ecosystem impact prices and what can be done to bring them down, though some are questioning whether anything subs...
  • Regulatory NewsRegulatory News

    Senate Committee Advances FDA User Fee Reauthorization Bill

    The Senate Committee on Health, Education, Labor & Pensions on Thursday advanced by a vote of 21-2 a bill that would reauthorize the pharmaceutical, medical device, generic drug and biosimilar user fee agreements that expire at the end of September. Two additional amendments were added to the latest version of the bill , one from Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Richard Burr (R-NC), and Bob Casey (D-PA) on expanded access to drugs and one from Sens...
  • Regulatory NewsRegulatory News

    Senate Committee to Vote on FDA User Fee Reauthorizations

    Next Wednesday, the Senate Committee on Health, Education, Labor & Pensions will vote on the five-year reauthorization of the four US Food and Drug Administration (FDA) drug, medical device, biosimilar and generic drug user fee agreements. The current, five-year agreements are set to expire 30 September 2017, though if Congress fails to act before its summer recess, thousands of FDA employees would receive layoff notices. The proposed reauthorizations, grouped ...