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  • 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...
  • New Legislation Seeks Creation of Provisional Approval Pathway for New Drugs

    Three US legislators have moved to introduce legislation they say would accelerate US Food and Drug Administration (FDA) approvals while giving patients the option to obtain therapies outside of clinical trials. Background US regulators now have a variety of tools at their disposal with which to accelerate the approval of pharmaceutical products. The most prominent of those tools are geared toward patients with serious diseases, and include fast track designation, acc...
  • Legislators Reveal Text of Veterinary User Fee Bills, Free from Potential Markups

    • 08 April 2013
    US legislators on the House of Representatives' Energy and Commerce Committee have finally released the draft versions of two bills that would serve to reauthorize industry-paid user fees for both innovative and generic veterinary medicines. Background The bills, the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) , are, like their human prescription drug and medical device counterparts, a mechanism by which the veterinary pharmace...
  • Proposed Senate Bill would Increase FDA Funding by $24 Million, Restore User Fee Funding

    The Senate version of a Continuing Resolution bill that recently passed the US House of Representatives would, like the House version, allow the US Food and Drug Administration (FDA) full access to user fees it now collects from generic pharmaceutical and medical device companies under the 2012 FDA Safety and Innovation Act , as well as some additional appropriated funding. The fees are responsible for partially funding the regulatory agency, which relies on them to be ...
  • Legislator: FDA Should Create New Office to Regulate Mobile Apps

    US Rep. Mike Honda (D-CA) plans to reintroduce a measure in Congress that would seek to establish a new office at the US Food and Drug Administration (FDA) dedicated to the development and oversight of mobile health technologies. Background Honda first introduced the measure in September 2012, late in the 112 th Congress. By rule, all measures not passed during the previous two-year congressional session must be reintroduced during the new session. His bill, the He...
  • Indonesian Pharmaceutical Industry Cries Foul over Potential New Dietary Law

    • 05 November 2012
    Vaccine manufacturers routinely have to deal with the difficulty of meeting science-based regulations. Such manufacturers operating in Indonesia may soon have another, and far more difficult, set of regulations to meet: Muslim dietary law, known as halal. UPI reports Indonesia's legislature is considering a measure that would require all pharmaceutical and biological products manufactured in the country to comply with Muslim dietary law, which includes a prohibitio...
  • 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...
  • As Compounding Crisis Widens, Legislators Propose Regulatory Fixes

    US legislators are scrambling to get to the bottom of a burgeoning crisis involving products compounded at a Massachusetts pharmaceutical compounder's facility that have thus far killed 11 people and infected more than 100, announcing hearings and new legislation meant to plug oversight gaps in the regulatory system. In a 9 October announcement , the House Energy and Commerce Committee said it had requested briefings from both the US Food and Drug Administration (FDA) a...
  • Proposed Legislation Calls for FDA to Form Office Dedicated to Mobile Apps

    Could the US Food and Drug Administration (FDA) stand to benefit from dedicating a department to the development and review of mobile health technologies? At least one legislator thinks so, and is preparing to introduce legislation requiring the agency to do just that, reports Kaiser Health News . The bill, the Healthcare Innovation and Marketplace Technologies Act (HIMTA) , is set to be introduced in the US House of Representatives by Rep. Mike Honda (D-CA) and calls ...
  • Bill to Enhance Fines, Penalties for Falsifying Medical Products Passes Congress

    • 24 September 2012
    A piece of legislation set to increase the amount of fines and severity of penalties for counterfeiters and thieves of medical products has passed both the US House of Representatives and Senate by unanimous consent. The legislation, known at the Strengthening and Focusing Enforcement to Deter Organized Stealing and Enhance Safety Act of 2010 (SAFE DOSES Act ) , was first introduced in March 2012 by Rep. James Sensenbrenner (R-WI). As reported by Regulatory Foc...
  • With Cuts to FDA Looming, Congress Prepares to Adjourn--Again

    Federal programs, including those of the US Food and Drug Administration (FDA), are under seige. Under the combined terms of a proposed budget resolution and budget sequestration, FDA stands to lose hundreds of millions of dollars in both congressionally appropriated and user fee-generated funding during the 2013 fiscal year. And, with just three months left in which to restore funding to FDA, Congress is preparing to adjourn-again. The Hill reports that the Senate...
  • Legislation Would Keep FDA Budget at 2012 Levels Through March

    Legislators in the US House of Representatives and US Senate are back in session and looking to pass legislation to keep government agencies funded through March 2013. The draft legislation of a tentative agreement between Democrats and Republicans, first announced before the start of the August 2012 congressional recess, would largely maintain current funding levels across federal agencies. The government would be funded with $1.047 trillion in appropriations-$26.6 ...