Search Results for drug pricing

Showing 1 – 25  of 27

Trump Administration Officials Huddle at White House to Discuss Drug Pricing By Zachary Brennan - Published 16 June 2017

A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients."

Categories: News, US, FDA, Drugs

Tags: Trump, drug pricing, White House meeting on drug prices

Canada Proposes to Amend Drug Pricing Regulations By Zachary Brennan - Published 17 May 2017

For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs.

Categories: News, Canada, US, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: drug pricing, Canada drug prices, QALY, PMPRB, generic drugmakers

Congress to Trump: Let’s Tackle Drug Pricing in User Fee Reauthorizations By Zachary Brennan - Published 15 May 2017

As part of a bid to bring down the price of pharmaceuticals in the US, Reps. Jan Schakowsky (D-IL), Keith Ellison (D-MN), Rosa DeLauro (D-CT) and 33 other House members sent a letter to President Donald Trump on Monday seeking a way forward to meet the promises he’s made on the campaign trail and since taking office.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: drug pricing, Trump, FDA user fees

WHO Officials Offer Opposition to Value-Based Drug Pricing By Zachary Brennan - Published 12 May 2017

World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing systems.

Categories: News, Asia, Canada, Europe, US, NICE, WHO, Biologics and biotechnology, Drugs, Government affairs

Tags: WHO on drug pricing, fair pricing forum, pharmaceutical pricing

European Regulatory Roundup: UK Hurries Drug Pricing Bill Ahead of Election (4 May 2017) By Nick Paul Taylor - Published 04 May 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Drugs

Tags: drug pricing, ANSM, UK election

Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017) By Nick Paul Taylor - Published 18 April 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory strategy

Tags: Asia regulatory roundup, India drug pricing, CFDA clinical trial, China drug regulations

European Regulatory Roundup: EMA Offers Guidance on Assessing Periodic Safety Update Reports (13 April 2017) By Nick Paul Taylor - Published 13 April 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: EpiPens, House of Lords, drug pricing, EMA guidance

Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals By Zachary Brennan - Published 05 January 2017

The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program.

Categories: News, US, Crisis management, Drugs, Government affairs

Tags: 340B, CMS, drug pricing, Medicaid, PhRMA, BIO, Bayer, Teva

European Regulatory Roundup: Proposal for a European Drug Pricing Initiative (6 October 2016) By Nick Paul Taylor - Published 06 October 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, Biologics and biotechnology, Drugs, Government affairs

Tags: EU Regulatory Roundup, drug pricing, cancer drugs fund

What Drugs Really Cost: GAO Wants CMS to Find Out By Zachary Brennan - Published 02 August 2016

In order to help ensure the accuracy of Medicare Part B drug payment rates, the US Government Accountability Office (GAO) on Monday urged Congress to require all manufacturers of Part B drugs paid at average sales price (ASP) to submit sales price data to the Centers for Medicare & Medicaid Services (CMS). 

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

Tags: GAO, CMS drug prices, Part B, drug pricing, ASP

Vermont Governor Signs Bill With Possible $10K Fines for Drug Price Hikes By Zachary Brennan - Published 03 June 2016

Vermont Gov. Peter Shumlin (D) on Friday signed into law a bill that would highlight drugs that the state spends significant amounts of money on, and companies owning those drugs could be hit with up to $10,000 in penalties if the wholesale acquisition costs rise too quickly and they fail to disclose the reasons for such hikes.

Categories: News, US, Drugs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: drug price transparency laws, drug price bills, Vermont drug pricing law

European Regulators Drawn Into Debate on Drug Pricing By Zachary Brennan - Published 12 May 2016

Although drug regulators aren’t supposed to be concerned with pricing when making decisions on products’ safety and efficacy, they’re increasingly being drawn into what two representatives of the European Medicines Agency (EMA) and the heads of two national regulators call an “acrimonious debate” over drug costs.

Categories: News, Europe, US, EC, EMA, MHRA, NICE, Biologics and biotechnology, Crisis management, Drugs, Government affairs

Tags: EU drug prices, pharmaceutical drug pricing, drug price policies, EMA and drug pricing

Senate Committee Offers Inside Look at the Rise and Fall of Valeant Pharmaceuticals By Zachary Brennan - Published 09 May 2016

The 800 pages of internal emails, correspondence and drug pricing statistics released by the Senate Special Committee on Aging over the weekend offers an inside look at how the multi-billion dollar Valeant Pharmaceuticals with 22,000+ employees jacked up the prices of a number of drugs, by as much as 6,000%, and then lamented the subsequent media and investor questions.

Categories: News, Canada, US, Compliance, Crisis management

Tags: Valeant Pharmaceuticals, drug pricing, pharmaceutical prices

European Drug Prices: New Commission Report on What Policies Work and What Could Work By Zachary Brennan - Published 25 February 2016

The complicated world of drug pricing presents an array of challenges for keeping costs low in the US and EU, though European countries are increasingly employing new policies to keep price gouging in check.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Reimbursement, Research and development

Tags: European Commission, EU drug pricing, HTA, external price referencing, differential pricing, pricing policies

Expectations for 2016: Drug Pricing, Biosimilars, LDTs and More By Zachary Brennan - Published 24 December 2015

The end of 2015 saw the news spotlight shift to pharmaceutical pricing, with increased government scrutiny that could lead to actionable reforms in 2016, though other major stories expected in the coming year may steal some of that light, including how the US biosimilars market and regulation of lab-developed tests (LDTs) will develop, the fate of the 21st Century Cures bill and more.

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Government affairs, In vitro diagnostics, Manufacturing, Medical Devices

Tags: biosimilars, LDTs, drug pricing, pharmaceutical spending

Regulatory Recon: Shkreli Arrested on Securities Fraud Charges (17 December 2015) Published 17 December 2015

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, Anvisa, CDSCO, DOJ, EMA, FDA, MHRA, TGA, Biologics and biotechnology, Business Skills, Combination products, Crisis management, Distribution, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices, Quality

Tags: Shkreli, generic drug pricing, Sarepta, biosimilars

Five Years of Cancer Drug Approvals: Most Cost Too Much and Give Us Too Little By Vinay Prasad MD, MPH - Published 17 December 2015

This is the guest post rebuttal (to this post from Mark Shapiro, VP of Clinipace) by Dr. Vinay Prasad, Assistant Professor of Medicine in the Division of Hematology Oncology in the Knight Cancer Institute. Prasad also holds appointments in the Department of Public Health and Preventive Medicine, and as Senior Scholar in the Center for Health Care Ethics at Oregon Health & Science University.

Categories: News, US, FDA, Clinical, Crisis management, Drugs, Government affairs

Tags: cancer drugs, oncology drug pricing, JAMA, cancer drug approvals

Five Years of Cancer Drug Approvals: Pricing, Novelty and Improvement By Mark Shapiro, MA, MBA - Published 17 December 2015

Mark Shapiro, vice president of clinical development at contract research organization Clinipace, considers a recent JAMA study on cancer drug pricing in a guest post for Focus. A rebuttal to this post by one of the authors of the JAMA article, Dr. Vinay Prasad, can be found here.

Categories: News, US, FDA, Drugs, Ethics, Government affairs, Manufacturing, Quality

Tags: cancer drug pricing, Clinipace, JAMA, novelty cancer drugs, oncology

New House Bill Seeks to Allow HHS to Negotiate Medicare Drug Prices By Zachary Brennan - Published 10 December 2015

Rep. Jan Schakowsky (D-IL) on Thursday introduced a new bill that would allow the Department of Health and Human Services (HHS) secretary to negotiate Medicare Part D prices for either sole-source drugs or biologics and are not manufactured by more than two drug companies.

Categories: News, US, Biologics and biotechnology, Business and Leadership, Drugs, Government affairs, Reimbursement

Tags: HHS, Medicare Part D, drug price negotiations, drug pricing, Schakowsky

Senate Committee Considers Priority Reviews to Stem the Tide of Off-Patent Drug Price Hikes By Zachary Brennan - Published 09 December 2015

Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.) hosted a hearing Wednesday to discuss steep price increases for off-patent drugs and what can be done to ensure patients and hospitals can afford these drugs moving forward.

Categories: News, US, FDA, FTC, Crisis management, Drugs, Ethics, Government affairs, Manufacturing, Reimbursement

Tags: drug pricing, Martin Shkreli, Turing, Daraprim, off patent drug prices, Senate committee

South American Health Ministers Negotiate Lower Prices for Antivirals, Antiretrovirals By Zachary Brennan - Published 20 November 2015

As the drug pricing debate continues in the US, the ministers of health of 10 Latin American countries recently persuaded pharmaceutical companies to lower the prices of several HIV/AIDS and hepatitis C treatments.

Categories: News, Latin America and Caribbean, WHO, Biologics and biotechnology, Drugs, Government affairs, Reimbursement

Tags: PAHO, drug pricing negotiations, Gilead, hepatitis C, MERCOSUR, South America

HHS Pharmaceutical Pricing Forum: Lots of Questions, Few Definitive Answers By Zachary Brennan - Published 20 November 2015

The Department of Health and Human Services’ (HHS) invite-only Pharmaceutical Forum on Friday turned out to be more of a listening session for a range of stakeholders to explain concerns and discuss a number of potential ways to lower drug prices, some of which involve US Food and Drug Administration (FDA) reforms.

Categories: News, US, FDA, Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Ethics, Government affairs, Regulatory strategy, Reimbursement, Research and development, Submission and registration

Tags: drug pricing, HHS pharmaceutical forum, Merck, Express Scripts, GPhA, IMS Health

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

AMA Calls to Ban DTC Advertising for Drugs, Medical Devices By Zachary Brennan - Published 17 November 2015

Physicians at the American Medical Association (AMA) on Tuesday called to ban direct-to-consumer (DTC) advertising for drugs and devices because of the negative impact of the commercially driven promotions.

Categories: News, US, FDA, Advertising and Promotion, Business and Leadership, Government affairs, Postmarket surveillance, Regulatory strategy, Research and development

Tags: AMA, drug pricing, DTC ads, pharmaceutical advertising, medical device advertising

Congress Looks to Halt Rise of Generic Drug Prices with New Rebates By Zachary Brennan - Published 02 November 2015

As drug price increases continue to make waves on the national level, Congress is taking the matter into its own hands by requiring generic drugmakers under the Medicaid Drug Rebate Program to pay higher rebates if generic prices rise too quickly.

Categories: News, US, Generic drugs, Regulatory intelligence, Regulatory strategy, Reimbursement

Tags: drug pricing, Medicaid, Medicaid rebates, drug rebate, AMP, inflation