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...

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...

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...

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...

A senator has become the second legislator in two weeks to call on the secretary of the Department of Health and Human Services (DHHS) to exercise an authority-one used only once in the agency's history-to overturn a recent regulatory decision by the US Food and Drug Administration (FDA). Background: Zohydro That regulatory decision was with regard to Zohydro ER (hydrocodone bitartrate), a pure hydrocodone pill approved by FDA on 25 October 2013. The approval decision w...

Legislators with the two committees that oversee the US Food and Drug Administration (FDA) want to know: What's holding up the agency's electronic labeling rule for pharmaceuticals? Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce uniformity were first passed. Those measures were substantially updated in 2006 under FDA's Requirements on Content and Format of Labeling for Human Prescript...

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 ...

Nearly two dozen members of Congress have written to leaders of the House of Representatives imploring them to exempt user fee-funded agencies like the US Food and Drug Administration (FDA) from having those fees taken away. Background The cuts are currently in place, the results of the Budget Control Act  of 2011 , which stated that if Democrats and Republicans were unable to come up with substantial, voluntary cuts to federal expenditures, an automatic trigger ...

Commissioners of the US Food and Drug Administration (FDA) tend to stay at the agency for a while. Current FDA Commissioner Margaret Hamburg, for example, has been with the agency since 2009. Predecessors Andrew von Eschenbach, Mark McClellan and David Kessler were there for two, three and six years, respectively. But unless the agency is disbanded or Hamburg is the lucky recipient of a new drug application for eternal life, she will eventually step down from her positio...

Have pity on the regulatory professional. Even under normal circumstances, the job of a regulatory professional-both those in government and in industry-is notoriously difficult, with long hours and highly complex and regulated material to work through. But even as pipelines have dried up and the stakes of regulatory approval have increased, regulators are dealing with one other challenge that has mostly flown under the radar: a parade of new legislative requirements. ...

A new report just published by the Government Accountability Office (GAO) confirms what US Food and Drug Administration (FDA) officials have long argued: They simply don't have sufficient authority to regulate compounding pharmacies with the same level of vigor as they do traditional pharmaceutical manufacturers. Background In the waning months of 2012, a massive outbreak of fungal meningitis was linked to supposedly sterile versions of methylprednisone acetate manufact...

House legislators are bringing new and critical attention to a proposed purchase of Virginia-based Smithfield foods, the world's largest pork processor, by Chinese company Shuanghui International, citing a past healthcare product regulation scandal that left dozens dead and few questions answered. Background In 2007 and 2008, regulators were left scrambling as dozens US citizens died after consuming products contaminated with adulterated heparin, a substance derived fro...