• Regulatory NewsRegulatory News

    FDA, Absent From Hearing, Makes the Case That it's Increasingly Innovative

    Yesterday, US legislators in the House Energy and Commerce Committee held a hearing to discuss how the federal environment—including the US Food and Drug Administration's (FDA) regulations—might be improved to bolster drug innovation. But while the pharmaceutical industry, device industry and patient groups found themselves well represented at the meeting, one prominent stakeholder found itself conspicuously excluded from the meeting: The US Food and Drug Administration. ...
  • House Committee Unveils Intent to Overhaul FDA Regulatory Framework

    A bipartisan group of legislators on the House Energy and Commerce Committee has launched a new initiative its members are calling the "21 st Century Cures Initiative," aimed at accelerating "the pace of cures and medical breakthroughs in the US." In a statement released on 30 April 2014, E&C committee members Fred Upton (R-MI) and Diana DeGette (D-CO) said they're looking to "broadly collaborate" with federal agencies, patients, scientists, academics and members of...
  • FDA Officials are Frequent Visitors to White House, Data Show

    Ever wonder how much influence the US Food and Drug Administration's (FDA) top regulatory officials have with the highest executive office in the land, the White House? If you buy the theory that access is tantamount to influence, the agency seems to have a good amount of it. Focus recently combed through four years of the White House's public visitor logs, querying the data to find instances in which some of FDA's top officials met with the president's staff, either a...
  • In Wake of Compassionate Use Debate, New Bill Promises Wider Access to Drugs and Devices

    New legislation introduced in the US House of Representatives this week would allow for the import, manufacture and sale of investigational drugs and devices meant to treat terminally ill patients. Overview and Background The bill, H.R. 4475, the Compassionate Freedom of Choice Act of 2014, comes in the midst of a long-running debate over whether current regulatory structures-and in particular FDA's Compassionate Use exemption process -is sufficient to treat termi...
  • Legislators Call for Government Investigation Into Industry Influence on FDA Approval of Painkiller

    As pressure continues to mount on the US Food and Drug Administration (FDA) over its October 2013 decision to approve a controversial pure hydrocodone painkiller known as Zohydro ER (hydrocodone bitartrate), several legislators are trying to convince the government itself to launch an investigation into the matter. Background: What is Zohydro? FDA approved Zohydro in October 2013. The approval decision was seen by many as surprising, as it followed an FDA advisory commi...
  • Bill Aims to Speed up Regulatory Process for Abuse-Prone Drugs

    A new piece of legislation introduced today by a bipartisan congressional duo calls for the improvement of a current regulatory stumbling block that some companies have likened to a "black hole." Background While the US Food and Drug Administration (FDA) determines whether a drug is safe and effective in the US, the determination of whether its component parts are addictive or prone to abuse falls under the authority of the US Drug Enforcement Administration (DEA) and t...
  • Bill Would Create Incentives to Seek New Approvals for Old Biologics

    A new bill introduced in the US House of Representatives on 24 March 2014 would grant companies additional patent protections for repurposed biological products. Bill Basics The bill, the Independent Innovator and Repurposing Act (IIRA) , is cosponsored by Reps. Joaquin Castro (D-TX) and Randy Forbes (R-VA) and is intended to provide "appropriate intellectual property protections" for some products. Those products, the bill explains, are any biologicals regulated un...
  • Pressure Mounts on FDA to Reconsider Approval of New Painkiller

    A group of legislators in the House of Representatives have become the latest group to introduce legislation that would seek to specifically ban a new hydrocodone painkiller recently approved by the US Food and Drug Administration (FDA)-an action some critics say would undermine the regulator's authority and set a dangerous new precedent. Background FDA approved Zohydro ER (hydrocodone bitartrate) in October 2013. The approval decision was seen by many as surprising, as...
  • CDRH Whistleblowing Scandal Back in Spotlight as Congress Again Takes Interest

    If US Food and Drug Administration (FDA) officials thought they had finally moved past a scandal that has embroiled the agency's medical device division for years, they apparently thought wrong. This piece has been updated with comment from FDA. See the FDA Comments' section . -Ed. Background On 26 February 2013, the US House Oversight Committee is set to re-examine a 2012 scandal involving FDA's Center for Devices and Radiological Health (CDRH) in which the agency ...
  • Waxman, Author of Legislation Creating Generic Drug Industry, Orphan Drug Provisions, to Retire

    Representative Henry Waxman (D-CA), a Democratic legislator who has been a fixture in Congress and a major influence in legislation shaping the US Food and Drug Administration (FDA) since 1975, has announced that he will retire at the end of his current term. Waxman, 74, served on and once chaired the Energy and Commerce Committee, which has jurisdiction over FDA in the House of Representatives. The legislator may be best known for his role in creating the generic drug ...
  • Senior Legislators Call for Investigation into Hacking of FDA Databases

    Senior Republican members of the House Energy and Commerce Committee have opened an investigation into the hacking of several databases maintained by the Center for Biologics Evaluation and Research (CBER), saying information provided to the public indicates that its databases may not have been properly secured. Background News of the hacking was first reported by Regulatory Focus on 11 November 2013, several days after the US Food and Drug Administration (FDA) quietl...
  • Legislators to OMB: Sequestration of FDA User Fees Wrong, Should be Reversed

    Legislators in the House of Representatives seem to have a consistent message for the White House's Office of Management and Budget (OMB), the office which effectively sets and enforces policy within the executive branch: Stop holding the US Food and Drug Administration's (FDA) user fees hostage. Background FDA's funding comes from a variety of different streams. While it receives a substantial amount of funding from the congressional appropriations process, it also rec...