• Regulatory NewsRegulatory News

    Catalyst Defends $375,000 Price Tag for Previously Free Drug

    In response to questions from Sen. Bernie Sanders (I-VT) on the price tag of a new orphan drug, Catalyst Pharmaceuticals on Thursday explained how much it had to invest in Firdapse (amifampridine) to bring it to market and how the previously experimental version of the drug should not be the standard of care. Firdapse is the first drug approved by FDA to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that affects patients' muscles and nerves....
  • Regulatory NewsRegulatory News

    Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky'

    As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach." Former commissioners Robert Califf, MD, Margaret  Hamburg, MD, Mark McClellan, MD, PhD and Andrew Von Eschenbach, MD, write that although in some shortage cases, importation of generic dru...
  • Regulatory NewsRegulatory News

    Bills Introduced in March: Importation, Cancer Drugs and PBM Transparency

    At least nine US House and Senate bills introduced in March would impact the pharmaceutical industry, including three to allow for more prescription drug imports from Canada, pharmacy benefit management (PBM) transparency and one on cost sharing for cancer medicines. With regard to importation, Rep. Elijah Cummings (D-MD) introduced a bill seeking to allow an increase of less costly medicines from Canada and Sen. Bernie Sanders (D-VT) introduced a similar measure . ...
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    Trump Working on ‘New System’ to Increase Drug Competition

    President Donald Trump tweeted Tuesday morning that he’s “working on a new system where there will be competition in the Drug Industry,” though how such a system would work alongside the current generic drug and biosimilar competitors, remains to be understood. On what such a system might entail, a White House spokesman told Focus : "The President has been steadfast in his commitment to reducing the regulatory burden on everyday Americans. As demonstrated through the ...
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    Democrats Revive Canada Drug Import Bill as Safety Questions Linger

    Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices. Sanders called the bill "critical" on Tuesday at a press conference, saying...
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    Sanders and Cummings Question $80,000 Price Hike of Ariad Cancer Drug

    Sen. Bernie Sanders (D-VT) and Rep. Elijah Cummings (D-MD) on Thursday questioned Ariad Pharmaceuticals CEO Paris Panayiotopoulous after the drugmaker hiked the price of its leukemia treatment by more than $80,000 in four years. The letter follows an exposé earlier this month in TheStreet , in which the company was called out for four price hikes of the leukemia drug Iclusig (ponatinib). The most recent 8% price hike means Iclusig now costs $16,561 per month, or nearly ...
  • Regulatory NewsRegulatory News

    Updated: Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen

    Sen. Amy Klobuchar (D-MN) this week called on the Senate Judiciary Committee to hold a hearing to investigate the more than 400% price increase of Mylan’s EpiPen, a potentially life-saving auto-injector for those suffering from severe allergies. Klobuchar joined fellow Democrat on the Judiciary Committee, Sen. Richard Blumenthal (D-CT), as well as former presidential hopeful Sen. Bernie Sanders (D-VT) in expressing outrage over the price hikes. And on Wednesday, Democrat...
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    FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote

    Three new expert committee meetings on opioids were announced by the US Food and Drug Administration (FDA) this week as two Democratic senators continue to oppose Robert Califf’s nomination as the next FDA commissioner ahead of a Senate vote on Monday. Before that vote, Sens. Ed Markey (D-MA) and Joe Manchin (D-WV) said they will hold a press conference to discuss why they’re opposed to Califf’s nomination. Markey has previously taken issue with FDA’s  approval of the us...
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    What FDA Can and Can’t Do to Help Lower Rising Drug Prices

    Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview. And sure enough, FDA doesn’t dip its toe into the pricing bog while deciding whether to approve or reject a new drug, and it also doesn’t negotiate with pharmaceutical companies over how to price drugs. But some FDA regulations do have a direct impact on drug prices, and with so...
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    Senators Hint at Confirmation of Califf as Next FDA Commissioner

    Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him. Califf did his best to quell any concerns over industry influencing his decisions as head of the agency and the majority of senators at the hearing seemed confident that his experience makes him the right...
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    How the Clinton, Sanders Plans to Lower the Rise of Drug Prices Will Impact the FDA

    Democratic presidential candidates Hillary Clinton and Sen. Bernie Sanders are attempting to take on an issue the US Food and Drug Administration (FDA) can't control: rising drug prices. But some of their proposals would directly impact FDA authority. On Tuesday, Clinton unveiled a plan that would decrease the market exclusivity for biologics from 12 years to seven years, require drugmakers to spend a minimum amount of money on research and development (R&D), bar ph...
  • Proposed Legislation Seeks to Avoid Duplicative Trials

    • 14 August 2012
    A new piece of legislation proposed in the US Senate would eliminate some requirements that sponsors conduct clinical testing on subjects, instead allowing some sponsors to enter into agreements with existing sponsors to access their clinical trials data-sometimes on a mandatory basis. The Ethical Pathway Act of 2012 would specifically allow sponsors of drugs, biologics and medical devices to, "Rely upon existing trials, subject to sharing of the costs of those tri...