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  • Lawmakers: Free up FDA's Sequestered User Fees

    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 ...
  • As US Senate Goes 'Nuclear,' Future FDA Commissioners Could Benefit

    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...
  • US Congress Takes Interest in Regulatory Process with Flurry of Laws not Seen Since Early 2000s

    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. ...
  • GAO Report Gives Credence to FDA's Pharmaceutical Compounding Claims

    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...
  • Legislators Say Acquisition of US Pork Supplier Would Imperil Safety, Availability of Heparin

    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...
  • Senator Calls for Prominent FDA Involvement in Drug Abuse Prevention Commission

    A new piece of legislation introduced in the Senate last week would see the involvement of the US Food and Drug Administration (FDA) in a panel of experts meant to curb the rising tide of prescription drug abuse. A New Committee The legislation, the Combating Prescription Drug Abuse Act (CPDA) , was introduced on 10 July 2013 by Sen. Barbara Boxer (D-CA) and would establish a commission of experts and stakeholders known as the Combating Prescription Drug Abuse Commissi...
  • Obama Signs Law Closing Vaccine Loophole

    • 26 June 2013
    US President Barack Obama has signed into law legislation intended to close a loophole that would have prevented a new vaccine manufactured by French manufacturer Sanofi from obtaining the same legal liability protections - and patients the access to injury compensation - as traditional vaccines. Background The problem doesn't have to do with the safety of Sanofi's quadrivalent vaccine, known as Fluzone. By all accounts the vaccine is extremely safe, and regulators have...
  • Republicans Dig Into FDA for Helping to Promote Obamacare Law

    If you've been paying close attention to the US Food and Drug Administration's (FDA) emails over the last several weeks, you've likely caught onto something unusual: the agency's promotion of something that has almost nothing to do with food, drug, medical devices or other regulated products. Background That thing, as it turns out, is the Patient Protection and Affordable Care Act (PPACA) - "Obamacare," if you like - President Barack Obama's signature health care over...
  • Legislators Move to Close Loophole Affecting Sanofi's New Influenza Vaccine

    When the US Food and Drug Administration (FDA) approved a new four-strain flu vaccine manufactured by French life sciences manufacturer Sanofi in early June 2013, it didn't just mark a momentous occasion for regulatory officials within Sanofi - it also exposed a potential loophole in how US officials accommodate the safety of vaccine products, one legislators are now eager to fix. Background The problem uncovered doesn't have to do with the safety of Sanofi's quadrivale...
  • Congress Presses DEA to Open up on Regulatory 'Black Hole'

    Once, professionals engaged in pharmaceutical regulatory affairs had only one agency to worry about: the US Food and Drug Administration (FDA), which has principal authority over whether a drug is safe and effective for use. But in recent years the US Drug Enforcement Agency (DEA) has begun to flex its influence on the approval of some products with the potential for abuse, and now members of Congress are taking notice, demanding answers about the lack of transparency in ...
  • Orphan Drug Manufacturers Would be Exempt from 'Obamacare' Fees Under New Bill

    A new piece of legislation introduced this week by Rep. Jim Gerlach (R-PA) would clarify that developers of orphan pharmaceutical products are exempted from an annual fee otherwise levied on manufacturers to help fund the government's expansion of national healthcare. Background Orphan drug products have long been exempted from a range of fees otherwise levied on other manufacturers. As defined under the Orphan Drug Act of 1983, orphan drugs are those intended to trea...
  • Veterinary User Fee Bills Pass Congress, Await Obama's Signature

    US legislators in the House of Representatives this week announced the passage of a package of user fees that would enhance what the US Food and Drug Administration (FDA) collects from members of the veterinary pharmaceutical industry. Background Passage of the legislation was in many ways overshadowed by the debate over and passage of another major piece of legislation that would reform security standards for the pharmaceutical industry, known as the Safeguarding Am...