• Legislator Says FDA's Plans for Expediting Drug and Device Approvals May Be too Ambitious

    A prominent legislator on the House of Representative's Energy and Commerce Committee, Rosa DeLauro (D-CT), has called on the US Food and Drug Administration (FDA) to answer questions about the integrity of its drug and device approval processes, saying some products may be receiving approval prematurely. The 6 February 2014 letter, addressed to FDA Commissioner Margaret Hamburg, notes the congresswoman's "growing concern over recent trends related to the approval of dru...
  • As Commissioner Hamburg Plans Official Visit to India, Regulatory Compliance in the Spotlight

    The commissioner of the US Food and Drug Administration (FDA), Margaret Hamburg, is at long last headed to India. The long-planned trip will reportedly focus on strengthening regulatory ties between FDA and the region's regulators, the Union Health Ministry and the Central Drug Standards Control Organization (CDSCO). The former is similar to the US Department of Health and Human Services (DHHS), while the latter is similar to FDA. India also has local regulatory depart...
  • Hamburg Takes Peer-Pressure Approach in Advocating for Safer Compounding Practices

    When Congress passed the Drug Quality and Security Act (DQSA) into law in November 2013, it did so with the contention that it would prevent the sort of egregious lapses that allowed a pharmaceutical compounder's products to kill dozens and leave hundreds more wounded in 2012. Under the status quo, pharmaceutical compounders were regulated largely by state-level regulators, usually state boards of pharmacy. But under the DQSA , compounders could voluntarily subject th...
  • Legislator Asks for FDA Evaluation of Several Novel Ideas to Solve Drug Shortage Crisis

    The issue of drug shortages may have largely fallen off the media's radar, but it hasn't stopped being a problem for consumers. Now, in a letter to the US Food and Drug Administration (FDA), Rep. C.W. Bill Young (R-FL) has called on Commissioner Margaret Hamburg to evaluate several new ideas that could act to mitigate or eliminate the shortage crisis. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drugs experien...
  • As FDASIA Celebrates First Year, FDA Says Drugs, Devices Already Seeing Benefit

    On 9 July 2012, US President Barack Obama quietly signed into law a piece of legislation that had received overwhelming support in both chambers of Congress - a relative rarity in the hyper-political 112 th Congress. That law, the Food and Drug Administration Safety and Innovation Act (FDASIA) , is now one year old, and the US Food and Drug Administration (FDA) is marking the occasion by talking about what it's been doing to implement the considerable number of provisio...
  • 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...
  • Hamburg: Lab-Developed Tests to be Subject to Heightened Scrutiny under New Framework

    For years, the US Food and Drug Administration (FDA) has provided leeway to a sub-category of diagnostic tests known as laboratory-developed tests, or simply LDTs. But according to FDA Commissioner Margaret Hamburg, that era of enforcement discretion will soon come to an end. Background Under normal circumstances, medical devices can reach the market in one of two ways. Either they obtain FDA approval through the premarket approval (PMA) process-a difficult and expensiv...
  • 43 Attorneys General: New Black Box Warning Needed to Prevent Neonatal Death

    The National Association of Attorneys General, an organization comprised of all state attorneys general, has sent a letter to US Food and Drug Administration (FDA) Commissioner Margaret Hamburg asking her to add a black box warning to all narcotic analgesics in the hopes of reducing risks to newborn children. The Letter At issue for the 43 signatories of the letter is the potential for opioid abuse by pregnant women to lead to Neonatal Abstinence Syndrome (NAS), a syn...
  • New Funding Required to Allow FDA to Face 'Brave New World' of Global Supply Chains, Says Hamburg

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg has found herself in front of a congressional hearing for the second time this week, this time under far more favorable circumstances explaining why the agency deserves the funding it receives and-hopefully-more of it. Globalization In prepared testimony delivered on 18 April 2013 to the Senate Committee on Appropriations, the congressional panel with principal authority over FDA's budget, Hamburg obser...
  • Hamburg Defends Agency's Response to Compounding Crisis, Floats User Fees as Potential Solution

    Arguing that the issue of the safety of compounded pharmaceutical products is now at a "critical point," US Food and Drug Administration (FDA) Commissioner Margaret Hamburg plans to tell legislators at a hearing today that her agency needs more resources and authority to better do its job, according to a copy of Hamburg's testimony. Background Legislators with the House of Representative's Energy and Commerce Subcommittee on Oversight and Investigations have for several...
  • Legislators, FDA Outline Cases in Advance of Major Hearing on Pharmaceutical Compounding

    Legislators and regulators alike have released previews of the arguments they intend to make at an upcoming hearing regarding a massive outbreak of fungal meningitis caused by deficient compounding practices at a Massachusetts facility, indicating that Tuesday's hearing could-once again-be a contentious one. Background Pharmaceutical compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without having first s...
  • Hamburg to be Hauled before House Committee again to Address Agency's Compounding Culpability

    Top officials with the US Food and Drug Administration (FDA) will against find themselves in the firing line of congressional legislators in the coming week as the House Energy and Commerce Committee says it's not finished probing the agency's response to a recent outbreak of fungal meningitis. Background Pharmaceutical compounding pharmacies enjoy a relatively unusual regulatory exemption in the US whereby they can compound products without having first sought regulato...