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  • Regulatory NewsRegulatory News

    TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

    After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers. TPP Early last month, a number of questions emerged over a sticking point ...
  • Regulatory NewsRegulatory News

    NICE to Work Earlier With Industry to Speed NHS Adoption of New Drugs, Devices

    The UK's National Institute for Health and Care Excellence (NICE) on Tuesday officially launched its Office for Market Access (OMA) to collaborate more closely with industry to accelerate the adoption of new drugs, devices and diagnostics by the National Health Service (NHS). Specifically, OMA will give commercial stakeholders access to a dedicated team at NICE that they can approach for inquiries relating to health technology evaluation, as NICE is responsible for...
  • Regulatory NewsRegulatory News

    'Right to Try' Legislation Tracker

    Since early 2014, more than 20 states have introduced so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments more easily. These bills are modeled off a federal policy known as " Compassionate Use ," but contain several key changes meant to make it faster and easier for patients to obtain experimental therapies. This Right to Try Legislation Tracker is meant to be a resource for...
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    RAPS Switzerland Chapter to Host 2015 EU Medtech Reimbursement Roundtable

    No healthcare product, no matter how innovative or essential, will make it to patients without regulatory approval. Every regulatory professional knows this. But there is another critically important factor involved in getting treatments to patients that you may not know as much about—a concept known as market access. The elements of market access include reimbursement and the evidence necessary to secure it from payers, pricing and coverage policy. These areas ...
  • Regulatory NewsRegulatory News

    Cancer Drugs First to Take Advantage of UK Early Access Scheme

    The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a second product under a new accelerated review process intended to make promising new drugs available to patients more quickly. The drug, Bristol Myers Squibb's Opdivo (nivolumab), joins Merck's Keytruda (pembrolizumab) as one of two products listed under MHRA's early access to medicines scheme (EAMS), both of which are intended to treat advanced melanoma. Background In March 2014, MHRA ann...
  • Regulatory NewsRegulatory News

    UK to Launch New Office for Market Access

    The UK's National Institute for Health and Care Excellence (NICE) is launching a new office to promote market access for innovative products through early engagement with companies. A proposal and outline for the Office for Market Access (OMA) was approved by NICE's Board of Directors on 20 May 2015. Background When a new medicine is approved in the UK, NICE is responsible for conducting a health technology assessment (HTA) to measure its cost-effectiveness and determ...
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    New FDA Program to Expedite the Approval of 'Breakthrough' Medical Devices

    The US Food and Drug Administration (FDA) has put the finishing touches on two policies intended to expedite access to potentially life-saving devices meant for patients with life-threatening diseases or conditions. Background FDA's Center for Devices and Radiological Health (CDRH) has for several years been putting the finishing touches on two conceptually related guidance documents: Expedited Access for Premarket Approval and De Novo Medical Devices Intended for U...
  • Regulatory NewsRegulatory News

    Bill Wants Drugs Approved in Europe to be Available More Quickly to US Patients

    New legislation introduced in the US House of Representatives this week would require the US Food and Drug Administration (FDA) to expedite the review and approval of pharmaceutical products already approved in Europe. Background The bill, the Speeding Access to Already Approved Pharmaceutical Act , is sponsored by Reps. Tim Ryan (D-OH) and Steve Stivers (R-OH), who introduced the same bill in June 2014 . As with the original, the bill targets something known in th...
  • Regulatory NewsRegulatory News

    Bill Would Give Some Reformulated Drugs Extra Protection from Generics

    New legislation introduced in the US House of Representatives would give some pharmaceutical products an extra two years of marketing exclusivity if their sponsors are able to demonstrate that the redesigned or reformulated drugs improve adherence, decrease abuse or otherwise make the drug safer to take. Background The bill, the Promoting Access for Treatments Ideal in Enhancing New Therapies (PATIENT) Act of 2015 , was introduced in the House on 13 March 2015 by Rep...
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    Medical Device Risk Management by Regulatory Authorities

    Regulatory Authorities are challenged to keep their markets open and to ensure that patients have proper access to devices while at the same time keeping non-compliant, possibly dangerous devices away from their populations. To achieve this they need to use risk control strategies. Authorities that are rethinking their approaches to risk management could consider a three-tier system: A 100% check on all devices for a limited number of items per device; A more extensive...
  • Regulatory NewsRegulatory News

    UK Regulator Issues First Positive Opinion in Early Access Program

    Merck’s new skin cancer treatment has become the first product approved under a new accelerated review process by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). The product, Keytruda, has been shown to be effective in slowing the progression of advanced melanoma, a deadly form of skin cancer with few treatment options. Accelerated Approval Keytruda is the first product to be approved under MHRA’s early access to medicines scheme (EAMS), whic...
  • Regulatory NewsRegulatory News

    From 100 Hours to 1: FDA Dramatically Simplifies its Compassionate Use Process

    In response to repeated criticism that terminally ill patients find it too difficult to obtain access to experimental and potentially life-saving drugs, the US Food and Drug Administration (FDA) has announced changes to its "compassionate use" process in the hopes of making it easier for physicians to request access to medical products on behalf of their patients. Background FDA's "compassionate use" process—formally known as its Expanded Access Program—is meant to allo...