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

 
  • Regulatory NewsRegulatory News

    FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote

    Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday. Before that vote, Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) said they will hold a press conference to discuss why they’re opposed to Califf’s nomination. Markey has previously taken issue with FDA’s  approval of the us...
  • Regulatory NewsRegulatory News

    Updated: Governor Takes Issue With Super Bowl Drug Ad as New House Bill Looks to Restrict DTC Pharma Advertising

    [Editor's note: This story was updated with new details on the text of the DeLauro bill to restrict DTC pharma advertising and new details on a letter from AstraZeneca to Gov. Shumlin]. Vermont Gov. Peter Shumlin (D) has sent a letter to pharmaceutical companies AstraZeneca and Daiichi Sankyo calling on them to pull their advertisement that aired during the Super Bowl. The ad promoted a drug to treat opioid-induced constipation. “Like many Americans, I was baffled by th...
  • New Legislation Aims to Provide FDA with New Authority to Regulate Compounders

    US Rep. Ed Markey (D-MA) plans to introduce a new piece of legislation he says will give the US Food and Drug Administration (FDA) new authority to regulate compounding pharmacies while still preserving state-level oversight authority. Markey's bill, the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2012 , is an attempt to rectify a "regulatory black hole" responsible for letting through dangerous products that have killed dozens of patients an...
  • House Democrats Take Aim at FDA, Call for Agency to Release Information

    The US Food and Drug Administration (FDA) is increasingly finding itself at the center of a burgeoning crisis involving steroid injections compounded by a Massachusetts pharmacy that have so far killed 12 and sickened dozens with meningitis. Two prominent members of the US House of Representative's Energy and Commerce Committee-the House's legislative vehicle for overseeing FDA and the pharmaceutical industry-have aimed their sights squarely on FDA, calling on the agen...
  • Legislators Call for Publicly Available 510(k) Database to Address 'Loophole'

    Two legislators have written to the US Food and Drug Administration's (FDA) top medical device regulator, calling on the agency to provide for public access information about medical devices cleared through FDA's 510(k) premarket notification process. The letter , sent 15 August by Rep. Edward Markey (D-MA) and Sen. Jeff Merkley (D-OR), observes that several medical devices once cleared through the 510(k) process have been subject to high-profile safety concerns and rec...
  • Clinical Trial Results to be made Public Under Proposed Legislation

    A new bill proposed in the US House of Representatives would require clinical trial sponsors to publish the results of any clinical trial-domestic or foreign-conducted in support of a product application before the US Food and Drug Administration (FDA). The bill, the Trial and Experimental Studies Transparency (TEST) Act of 2012 , was introduced by Rep. Ed Markey (D-MA), a member of the House Energy and Commerce Committee whose oversight duties include the healthcar...
  • PREA, BPCA Reauthorization Bill Introduced in House of Representatives

    A bipartisan trio of Representatives introduced a bill that would reauthorize the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) , marking an attempt to further a program that has been widely praised for establishing greater safety for pediatric medications. The bill, To amend title IV of the Public Health Service Act and title V of the Federal Food, Drug, and Cosmetic Act to permanently extend the provisions of the Best Ph...
  • Congressman Calls for Closure of Medical Device 'Loophole' in Report

    • 26 March 2012
    • By
    Massachusetts Democrat Edward Markey is calling for the stricter regulation of medical devices and the closure of a so-called "loophole" in the US Food and Drug Administration's (FDA) 510(k) pathway that currently allows medical devices to be approved even if they are based on a device since recalled for safety defects. Markey held a press conference on 22 March to both release a report entitled "Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected Fr...
  • Bill Would Encourage FDA to Seek Expert Advice About Rare Diseases

    Proposed legislation introduced in Congress on 7 March would encourage the US Food and Drug Administration (FDA) to seek and receive advice from experts in the field of rare diseases. The Expanding and Promoting Expertise in Review of Rare Treatments Act of 2012 ( EXPERRT Act ) would allow a consultation programs to be established for the purpose of allowing an exchange of expert information. The goal of the program is to allow FDA staff to better inform and strengthen...
  • Duo of US Bills Aim to Prevent Drug Shortages, Amend 510(k) Pathway

    Representatives John Carney (D-DE) and Ed Markey (D-MA) both introduced bills this week that would, respectively, aim to prevent drug shortages and grant the US Food and Drug Administration (FDA) the authority to prevent medical devices from claiming substantial equivalence to a recalled medical device. Carney's bill, the Drug Shortage Prevention Act of 2012 , would amend Chapter V of the Federal Food, Drug and Cosmetic Act ( FD&C Act ) to require FDA to establi...