Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts

Tuesday, December 6, 2016

Senate Approves Faster Approval Process for FDA

Feeling "trumped" lately? Yeah, we know the feeling. With the 2016 election beyond us, and a new administration among us, health care reform and policy advocates are split between the two worlds of what's now and what could be.

"The Senate Monday cleared the final hurdle to passage of broad legislation aimed at boosting federal funds for biomedical research and speeding up government approval of drug and medical-devices, a goal pursued by the pharmaceutical industry over the objections of some consumer advocates," reports the WSJ.
The 85-13 vote cuts through the last remaining procedural obstacle before passage in the Senate, expected by Wednesday. Last week, the House overwhelmingly passed the legislation, which is expected to be signed into law by President Barack Obama before his term ends

Monday’s vote easily cleared the needed 60-vote threshold to advance the bill, but showed some scattered opposition in both parties. Eight Democrats, four Republicans and one independent opposed advancing the bill, including Chuck Schumer (D., N.Y.) who will be Senate minority leader next year, and Rob Portman (R., Ohio). Both were protesting congressional inaction on legislation to shore up health-care and pension plans for certain retired coal workers, who were courted by politicians during the elections. But those lawmakers so far haven’t been able to persuade GOP leaders to schedule a vote on the legislation. 

In conjunction to speeding up the approval process for the Food and Drug Administration, the bill also approves $1 billion in funding to prevent and treat opioid addiction and eliminate the length process for agency approvals for grants to treat mental illnesses.

These topic, among a growing list of other reform and policy conversations, will also be a hot topic during the annual FDA/CMS summit in Washington D.C.

Our list of keynotes include health care professionals, drug reform and policy experts Janet Woodcock, John Coster, John Bardi, Cynthia Bens, Luciana Borio and Molly Burich.

Download our agenda here >>> goo.gl/ApvygU
Get $300 off when you register using code: 300CMS >>> goo.gl/3Du3W






Friday, November 21, 2014

Health Care Insights | Weekly Round Up

Health Care Insights brings you your weekly healthcare round up*. Below you will find relevant articles on key industry topics that we thought our readers would benefit from - enjoy.

Top Stories:
 

Healthcare's Big Data Opportunity
Global healthcare is at a pivotal moment in its history, on a par with Alexander Fleming’s discovery of penicillin and Louis Pasteur’s groundbreaking work with sterilization. As the quantity of data we generate rapidly expands and we continue to develop the computational power to store it, health authorities will be able to gather more information about their patients in a single year than has been open to them in all history.

Wearable Technology And Digital Healthcare Strategies Should Shift Focus To Chronic Medical Illness

As we marvel at the gadgets that companies such as Nike, Fitbit, Jawbone and Apple have recently produced and brought to market–gadgets that can record our heart rate, calories expended, and steps taken—one can only think of how this technology could likely be used on a greater scale to help those who truly need it the most: people with chronic medical illnesses such as emphysema, diabetes, or congestive heart failure.

 FDA approves Purdue's painkiller that can reduce abuse
The U.S. Food and Drug Administration has approved a long-acting narcotic painkiller with abuse-resistant properties made by Purdue Pharma L.P., the agency said on Thursday. The FDA approved the once-daily drug, Hysingla ER, with the expectation that it will reduce, though not necessarily prevent, abuse through snorting or injecting.

CMS Names Niall Brennan as Nation's First Chief Data Officer  
(Niall Brennan will be speaking at the FDA/CMS Summit for Payers)

On Wednesday, CMS announced Niall Brennan will become the agency's first chief data officer and will be responsible for overseeing efforts to improve data collection and transparency and leading the department's new Office of Enterprise Data and Analytics

Have a great weekend!


*Health Care Insights has no affiliation with any of the above publications. These articles are aggregated by our team based upon our audience's areas of interest.




Tuesday, September 23, 2014

AHIP CEO Ignagni to headline FDA/CMS Summit for Payers

IIR is pleased to announce that Karen Ignagni, President and CEO of AHIP has been added to the speaking faculty at the upcoming FDA/CMS Summit for Payers. Ignagni, the voice of health insurance plans, will headline a keynote session on Pricing and Reimbursement - The Tipping Point in the Future of Healthcare. Recognized as one of the strongest and most effective lobbyists in Washington, Ignagni will provide compelling insights and a valuable perspective. Download the newly updated brochure here.

The Inaugural FDA/CMS Summit for Payers, scheduled for December 11-12 at the Fairmont Washington, will bring together the FDA, CMS and C-Level health plan and pharma executives to collaborate on important industry issues, including innovative technology, pricing and personalized medicine. Together we will tackle monumental issues facing the healthcare industry—such as the approval of the Hepatitis C drug, Sovaldi, as well as the impact of the ACA and the significant changes it has brought about to your daily operations.

Plus, if you register by this Friday September 26th you will save $500! Click here to reserve your seat and please mention the code XP1917BLOG for your special savings.





Thursday, August 28, 2014

Your First and Only Chance to Hear the FDA & CMS Address Payers and Pharma Under One Roof

 
Introducing the FDA/CMS Summit for Payers


The Full Agenda is Now Available | Download Now! 
 
 
Hear the challenges and opportunities on key issues in order to succeed in a patient-centric environment. Plus:

• Get face-to-face access to the top regulatory thought leaders and policy makers from FDA and CMS
• Hear about critical trends and changes so you can create successful strategies for dealing with FDA and CMS
• Walk away with practical, real life lessons from some of the most experienced payers and healthcare executives on how they are dealing with the changes
• Benchmark your operational, regulatory and strategy against all the major health plans

Meet Regulators from FDA and CMS:

• Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA
• John K. Jenkins, MD, Director of the Office of New Drugs, Center for Drug Evaluation and Research, FDA
• Tamara Syrek Jensen, JD, Deputy Director, Coverage and Analysis Group (CAG), CMS
• Niall Brennan, Acting Director, Offices of Enterprise Management (OEM), CMS


Collaborate with C-Level Healthcare Leaders:

• Dr. Trent T. Haywood, MD, JD, Chief Medical Officer & SVP, Office of Clinical Affairs, Blue Cross and Blue Shield Assc.
• Dr. Claire Levesque, Chief Medical Officer for Commercial Products, Tufts Health Plan
• Dr. Richard Migliori, MD, Executive VP, Medical Affairs, Chief Medical Officer, UnitedHealth Group
• David Polakoff , MD, M.Sc, Chief Medical Officer & Associate Dean, Commonwealth Medicine Director, Center for Health Policy and Research, University of Massachusetts Medical School   
• William Winkenwerder, Jr.,  Former CEO, Highmark, Inc.
• Kevin Volpp, MD, PhD, Founding Director, Center for Health Incentives and Behavioral Economics, Leonard Davis Institute


Register now with the code XP1917BLOG and take an additional $100 off the current rate - $500 in total savings. Register here.




Monday, August 25, 2014

Announcing FDA/CMS Summit for Payers | Download the Brochure

With healthcare spending exceeding 18 percent of GDP and 30 cents of every healthcare dollar lost to waste, it's about time we looked into the potential to streamline, improve, and perhaps transform our current system.

In today's rapidly evolving healthcare environment, qualify patient care is critical and requires seamless coordination & communication among all stakeholders in the healthcare continuum. The days of working in silos are over.

IIR's invites you to the brand-new FDA/CMS Summit for Payers, which will focus on how health plans can better interact with government to remain compliant, adaptive, and successful.

The meeting will focus on relevant legislation, regulation, and accompanying guidelines, and will be composed of policy makers from FDA & CMS together with payers, providers and pharmaceutical manufacturers. Each stakeholder will discuss and share their perspective on how businesses and government can work together to drive positive policy change through collaboration.


Your first and only chance to hear the FDA and CMS address payers and pharma under one roof

• Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, FDA
• John K. Jenkins, MD, Director of the Office of New Drugs, Center for Drug Evaluation and Research, FDA
• Tamara Syrek Jensen, JD, Deputy Director, Coverage and Analysis Group (CAG), CMS
• Niall Brennan, Acting Director, Offices of Enterprise Management (OEM), CMS

Hear real life case studies and benchmark your strategies against major health plans and game changers

• Dr. Trent T. Haywood, MD, JD, Chief Medical Officer & SVP, Office of Clinical Affairs, Blue Cross and Blue Shield Assn.
• Dr. Claire Levesque, Chief Medical Officer for Commercial Products, Tufts Health Plan
• Dr. Richard Migliori, M.D, Executive VP, Medical Affairs, Chief Medical Officer, UnitedHealth Group
• David Polakoff , M.D., M.Sc, Chief Medical Officer & Associate Dean, Commonwealth Medicine Director, Center for Health Policy and Research, University of Massachusetts Medical School   
• William Winkenwerder, Jr.,  Former CEO, Highmark, Inc
• Kevin Volpp, MD, PhD, Founding Director, Center for Health Incentives and Behavioral Economics, Leonard Davis Institute

Your Ecosystem is evolving...are you part of the paradigm shift?

Register now and save $400 - Plus take an EXTRA $100 off when you use the code XP1917BLOG | That is $500 in total savings!  Register.

See you in D.C. this December!




Wednesday, August 20, 2014

The Impending Changes of Health Care Reform


The Impending Changes of Health Care Reform | Jesse Mendelsohn, Director of Global Customer Services & Support, Model N, sat down to discuss the preparation of systems and processes to accommodate the impending changes of the Health Care Reform.

At MDRP 2014, join one of our esteemed keynote speakers Mark McClellan, MD, PhD, Senior Fellow and Director, Health Care Innovation & Value Initiative, Brookings Institution, Former Commissioner, FDA, Former Administrator, CMS - as he dives deeper into this topic with his session titled - Health Care Reform and the Future of Medicaid


Make sure you join one of the 2014 event sponsors, Model N at MDRP this September 15-17 in Chicago - Blog readers save $100 when registering with the code XP1958BLOG | Register Today!




Tuesday, July 29, 2014

MDRP Lifetime Achievement Award

Each year the MDRP audience selects who should receive the “Lifetime Achievement Award.” Nominations are now open. Make sure to get your choice in for consideration now.


As the longest running MDRP conference, we are honoring the best and recognizing the dedication of those who have propelled this industry forward. Please submit your award nomination(s) here. We have divided the nominations by role in the industry, as so many have worked together to make the Medicaid Drug Rebate Program what it is today. The deadline for nominations is Monday, August 11, 2014 and the winners will be announced at the event during the networking reception on Tuesday, September 16th - So make sure you register to attend the event now. Save $300 when you register by 8/8 with the code XP1958BLOG.

To learn more about the program, download the brochure now. 

See you in Chicago this September!




Thursday, July 24, 2014

How Can We Sustain the Innovation of Biopharmaceuticals?

Welcome to the Specialty Pharmacy Collaboration Summit Podcast Series. Today we are speaking with Robert Popovian, Senior Director, US Government Relations, Pfizer Pharmaceuticals.


What needs to happen in the US to sustain the innovation initiative of biopharmaceuticals?

Robert: Well, biopharmaceuticals is a complex issue and a lot of people try to make it a very simple one by saying to do regulatory reform through the FDA or provide additional NIH funding to do research. Biopharmaceutical innovation policies are very complex and inter-dependent onto one another. There is no one magic bullet.

So, there are three distinct environments that need to be addressed to really sustain the biopharmaceutical innovation marketplace in the US and that is the investment environment, which is basically appropriate and electoral property protection. For example, tax policy, ability to price medicines according to the marketplace.

There is the regulatory environment, which is the second environment, which requires that we do a better job of streamlining not only the FDA, but other regulatory bodies like the Centers for Disease Control. And then, more importantly, within the regulatory policy framework is how to better do clinical trials and clinical trial recruitment. That needs to be addressed.

Finally, it is the access, which in my opinion is the one that is short shifted a lot of times because unless you address the access environment for biopharmaceutical, no matter if you are investing a lot of money in it or you have a very deregulatory process to get the product out, if the patients are unable to access those medicines because they are too high cost regarding out-of-pocket costs or there is no meaningful way to get access to it because there is no way to communicate that information to the providers, innovation will suffer and patients will suffer long term with that.



To hear more from Robert, please join him at IIR's Specialty Pharmacy Collaboration Summit, September 15-17 in Boston. Also, you can save an EXTRA $100 off the current rate, $500 in total savings when registering by 7/25 with the code: XP1968BLOG - Register now. 

See you in Boston!




Wednesday, June 11, 2014

4 Key Challenges in the Specialty Pharmacy Ecosystem


 Is the Specialty Pharmacy Model Sustainable?

At IIR's all-new Specialty Pharmacy Collaboration Summit on September 15-17, 2014 in Boston, join leading pharmaceutical manufacturers, health plans, and specialty pharmacies as they participate in in-depth sessions, roundtables and panel discussions to address the four key challenges in the specialty pharmacy ecosystem:

1. Adherence
Excellus, Bluecross Blueshield, Denver Health Medical Plan, Tufts Health Plan
Hear from experts in a payer specific panel as they shed light on commercial plan strategies and priorities.

2. Managing Costs and Determining Value of Specialty Drugs
 Pfizer
Robert Popovian, Senior Director, US Government relations of Pfizer will address the optimal methodologies to assess the value and cost proposition of specialty drugs in the evolving payment policy environment 

3. Distribution of Specialty Drugs and Channel Management
 Sanofi + Dana-Farber Cancer Institute, Harvard University
Develop distribution strategies to sustrain commerical success and learn how to postition withing the channel to gain a competitive adcantage with Richard Peters, MD, PhD, Division Medical Officer, Sanofi and Sylvia Bartel, VP Pharmacy, Dana-Farber Cancer Institute, Harvard University

4. Sustainability of the Specialty Pharmacy Model
National Association of Specialty Pharmacy + Independent Health
Gary Cohen, BSPharm, RPh, CSP, CEO, National Association of Specialty Pharmacy and Mike Reilly, President, Pharmacy Benefit Dimensions, Independent Health join together to discuss what the future holds for specialty pharmacy

Download the brochure for the full agenda and speaker details

Don't miss out! Register now to save up to $600! Plus take an EXTRA $100 off when you use the code XP1968LINK - $700 in total savings! Click here to register.

See you in Boston!




Thursday, May 8, 2014

SAVE THE DATE! IIR's 19th Annual Medicaid Drug Rebate Program Summit

THE authoritative MDRP event for everything government pricing, rebates, and regulation is back this September 15-17, 2014. IIR's 19th Annual Medicaid Drug Rebate Program Summit is the largest event in the space with the most speakers and government representations as well as 500+ MDRP executives ensuring you have the most comprehensive educational experience over three days.

Register now and take an extra $100 off the current rate with Priority Code: XP1958BLOG

Year after year, MDRP Chicago continues to be THE industry event where you and your teams get essential regulatory updates from key federal and state government officials. 2014 highlights include:
  • MDRP Compliance and Medicare Part D Proposed rule updates from CMS
  • Annual Update on the 340B Program and 340B Mega Rule from HRSA
  • 12th Annual States Dispute Resolution Meetings where you can realize millions in potential savings with 15 (and counting!) States
  • All new Legal & Compliance track and never before offered CLE credits for legal counsel
  • And more!

Plus, hear from our two industry keynotes share their first-hand experience in managing the true impact of the ACA and Medicaid reform:
  • Mark McClellan, MD, PhD, Senior Fellow. Brookings Institution; Former Commissioner, FDA; Former Administrator, CMS
  • Grace-Marie Turner, President, Galen Institute

Stay tuned for the final agenda announcement.

Register now for the lowest registration rates of the year plus take an extra $100 off when you use the code: XP1958BLOG. That is $500 off the standard rate – register today!




See you in Chicago!


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Wednesday, January 28, 2009

Expanded Coverage of Cancer Care Still an Issue

Yesterday we posted that Medicare has decided to expand coverage for cancer drugs because of the increased cost of care. Part of the policy allows coverage of cancer treatments that have not yet been approved by the FDA. Today I came across several more posts from AAARP Bulletin Today and TopNews. What is your take on the policy? Do you support it?