Search Results for Sanders

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Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky' By Zachary Brennan - Published 20 March 2017

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."

Categories: News, US, FDA, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: drug imports, Bernie Sanders, Califf, Hamburg, commissioners on drug imports

Bills Introduced in March: Importation, Cancer Drugs and PBM Transparency By Zachary Brennan - Published 17 March 2017

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.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: Cummings, Sanders, drug prices, PBMs

Trump Working on ‘New System’ to Increase Drug Competition By Zachary Brennan - Published 07 March 2017

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 generic drug and biosimilar competitors, remains to be understood.

Categories: News, US, FDA, Drugs, Government affairs

Tags: Trump, drug prices, Cummings, Sanders, FDA regulations

Democrats Revive Canada Drug Import Bill as Safety Questions Linger By Zachary Brennan - Published 28 February 2017

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.

Categories: News, Canada, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: Canada pharmaceutical imports, Bernie Sanders, drug costs, Rx import bill

Sanders and Cummings Question $80,000 Price Hike of Ariad Cancer Drug By Zachary Brennan - Published 20 October 2016

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.

Categories: News, US, FDA, Drugs, Government affairs

Tags: Ariad, Iclusig, Bernie Sanders, drug companies

Updated: Senate Judiciary Committee Members Call for Investigation Into Price Increases of Mylan’s EpiPen By Zachary Brennan - Published 22 August 2016

Sen. Amy Klobuchar (D-MN) on Saturday 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.

Categories: News, US, FDA, FTC, Business and Leadership, Crisis management, Drugs, Government affairs, Medical Devices, Quality

Tags: EpiPen, Mylan, Andy Slavitt, Bernie Sanders

FDA Calls for New Opioid Hearings as Califf Readies for Monday’s Senate Vote By Zachary Brennan - Published 19 February 2016

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.

Categories: News, US, FDA, Compliance, Crisis management, Postmarket surveillance, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: opioids and FDA, Califf, Senate vote for Califf, Manchin, Markey, Bernie Sanders

What FDA Can and Can’t Do to Help Lower Rising Drug Prices By Zachary Brennan - Published 18 November 2015

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.

Categories: News, US, FDA, Compliance, Drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: FDA, drug pricing, Robert Califf, Bernie Sanders, drug imports, ANDA backlog, generic drugs

Senators Hint at Confirmation of Califf as Next FDA Commissioner By Zachary Brennan - Published 17 November 2015

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.

Categories: News, US, FDA, Biologics and biotechnology, Blood, Clinical, Combination products, Drugs, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance, Preclinical, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: Califf, Senate HELP, FDA commissioner, Senate confirmation hearing, Duke University, Margaret Hamburg, Elizabeth Warren, Bernie Sanders

How the Clinton, Sanders Plans to Lower the Rise of Drug Prices Will Impact the FDA By Zachary Brennan - Published 22 September 2015

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.

Categories: News, US, FDA, Drugs, Government affairs, Regulatory intelligence, Submission and registration

Tags: Hillary Clinton, Bernie Sanders, drug pricing, FDA, generic drugs, biosimilars

Proposed Legislation Seeks to Avoid Duplicative Trials By Alexander Gaffney - Published 14 August 2012

Tags: Sanders, Legislation, Latest News, Senate, Bill, clinical trial, data

Senator Looks to Spur Development of Medicines Through 'Prize Fund' By Alexander Gaffney - Published 15 May 2012

Tags: Hatch-Waxman, Prize Fund, Sanders, AIDS, HIV, Patents, Latest News, Senate, Congress, innovation