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Pharmaceutical Executive April 1, 2011 |
Revisiting Reform Courts, Congress review policies and programs shaping drug costs and access. |
Pharmaceutical Executive January 1, 2014 Jill Wechsler |
Pharma Challenges for 2014 Pricing and personalized medicine are key themes shaping drug development and marketing |
Pharmaceutical Executive January 1, 2012 Jill Wechsler |
New Year, New Issues Look for action in 2012 on drug access, shortages, innovation, and transparency. The 800-pound gorilla in the room is the looming Supreme Court decision on the constitutionality of the Obama health reform legislation. |
Pharmaceutical Executive February 1, 2013 Jill Wechsler |
Breakthrough Year for New Drugs More new medicines gained market approval, but marketers face resistance from payers looking to cut healthcare spending. |
Pharmaceutical Executive September 1, 2011 Jill Wechsler |
Rebates and Reform User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight. |
Pharmaceutical Executive December 1, 2012 Jill Wechsler |
Obamacare, Innovation and Pricing Tax and budget decisions will shape the healthcare market and drug research and regulation. |
Pharmaceutical Executive January 1, 2011 Jill Wechsler |
Politics & PDUFA Pharma companies will assess health reform, negotiate user fees and keep an eye on federal prosecutors in the year ahead. |
Pharmaceutical Executive December 1, 2008 Jill Wechsler |
Challenge and Challenges Expanded healthcare coverage also fits the goals of pharma manufacturers. |
Pharmaceutical Executive August 1, 2012 Jill Wechsler |
Fleshing Out FDASIA Medical apps, e-submissions, counterfeit drugs, and imports tucked into fairly "clean" user-fee renewal legislation. In late June leading legislators reached across party lines to quickly approve the Food and Drug Administration Safety and Innovation Act. |
Pharmaceutical Executive December 1, 2011 Jill Wechsler |
FDA Gets a New Look Agency expansion and globalization promote innovation, collaboration, and organizational changes |
Pharmaceutical Executive June 1, 2014 Jill Wechsler |
What Price Innovation? Payers, drug plans seek clear assessment of drug value to rationalize high drug prices. |
Pharmaceutical Executive October 1, 2012 Jill Wechsler |
Changes and Challenges at FDA New user fee programs precipitate major changes at an agency under constant and intense scrutiny. |
Pharmaceutical Executive March 1, 2012 Jill Wechsler |
When Talk is Not So Cheap FDA and industry are pushing user fees, while they struggle with curbs on communications. |
Pharmaceutical Executive March 1, 2013 Jill Wechsler |
Another Round of FDA Legislation? Pressure for action on key enforcement and regulatory issues may prompt congressional action this year. |
Pharmaceutical Executive April 10, 2014 |
Obama Policies Reshape Pharma Marketing Health reform initiatives promote transparency, challenge reimbursement, writes Jill Wechsler. |
Pharmaceutical Executive February 1, 2006 Jill Wechsler |
Washington Report: Cross-Agency Collaboration for Part D Medicare Part D gives CMS more clout over coverage, pricing, and even drug development. |
Pharmaceutical Executive April 1, 2009 Jill Wechsler |
Kickoff for Reform In addition to overhauling healthcare, Congress is weighing proposals for updating FDA policies and expanding access to drugs. |
Pharmaceutical Executive February 1, 2009 Jill Wechsler |
Securing Savings A close look at the healthcare industry will separate real cost-cutting measures from money-saving myths. |
Pharmaceutical Executive February 1, 2012 Jill Wechsler |
Costs and Benefits of Health Reform Will expanded markets and accountable care organizations offset higher rebates, added fees, and closer scrutiny of marketing and prices? |
Pharmaceutical Executive December 1, 2010 Jill Wechsler |
New Ballgame in Washington Republican gains in Congress create uncertainty for health reform, drug regulation, and biomedical research |
Pharmaceutical Executive September 1, 2012 Jill Wechsler |
Costs, Coverage, and Court Decisions Its election season and drug pricing issues are once again front and center in the policy wars on managing the high cost of healthcare. |
Pharmaceutical Executive January 1, 2007 Jill Wechsler |
Washington Report: A Full Plate It's going to be a busy year in Washington for the pharmaceutical industry. Drug safety, unapproved uses, e-data requirements, and a shift to personalized medicine are just a few of the hot issues on tap for 2007. |
Pharmaceutical Executive October 1, 2011 Jill Wechsler |
At the Helm of Industry As the lead FDA official overseeing the testing and approval of new drugs and biotech therapies for some 20 years, Dr. Janet Woodcock has built a robust and modern drug regulatory system. |
Pharmaceutical Executive November 1, 2012 Jill Wechsler |
Budgets, Biosimilars, and Bad Ads While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives. |
Pharmaceutical Executive June 1, 2012 Jill Wechsler |
Innovation and Collaboration A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market. |
Pharmaceutical Executive October 1, 2011 Jill Wechsler |
An 'A' for Advancing Expectations As head of both the Food and Drug Administration and the Centers for Medicare and Medicaid Services, Mark McClellan has been at the center of public policy affecting the pharmaceutical industry over the last decade. |
Pharmaceutical Executive June 1, 2013 Jill Wechsler |
Washington Report: Innovation, Coverage, and Costs The backlash against high prices for new medicines will impact research, patent exclusivity, and drug benefits. |
Pharmaceutical Executive February 1, 2014 Jill Wechsler |
Drug Coverage, Costs Under Scrutiny Benefits offered by insurance plans on health exchanges and through Medicare are raising concerns about patient access to needed therapies |
Pharmaceutical Executive November 1, 2011 Jill Wechsler |
The Drug Shortages Struggle Clamor for critical therapies prompts probes of prices, production practices. |
Chemistry World March 25, 2010 Rebecca Trager |
Big pharma scores in US healthcare reform President Obama has signed the biggest US healthcare reform since the 1960s, and although it is largely seen as a victory for the pharmaceutical industry, some analysts are characterising it as a 'double-edged sword'. |
Pharmaceutical Executive July 1, 2009 Jill Wechsler |
Safety and Security As FDA looks to balance risks and benefits, more regulations are on the horizon. |
Pharmaceutical Executive November 1, 2005 Jill Wechsler |
Washington Report: Out of Commission? Crawford Steps Down The clouded circumstances of the commissioner of the Food and Drug Administration may complicate the process of securing a permanent leader. Meanwhile, battles continue over hot-button issues such as the morning-after pill and the regulation of follow-on biologics. |
Pharmaceutical Executive August 1, 2013 Jill Wechsler |
Costs and Coverage Challenge Medicare Drug Plans Rate cuts and fraud concerns create problems for Part D plans and Part B providers. |
Pharmaceutical Executive January 1, 2009 Jill Wechsler |
FDA Turnaround Time Will more resources and new leadership fix FDA, or is a major overhaul in order? |
Pharmaceutical Executive November 1, 2014 Jill Wechsler |
Outrage Grows Over Drug Pricing Insurers, physicians attack high-cost therapies in anticipation of specialty drug surge. |
Pharmaceutical Executive October 1, 2008 Jill Wechsler |
Part D Under Attack Congressional leaders ready campaign to curb Medicare drug plans. |
Pharmaceutical Executive June 1, 2007 Jill Wechsler |
Washington Report: Shop and Compare Insurers and payers believe that more comparative information on medical treatments will save money and improve care, but such analysis may be costly to pharma. |
Pharmaceutical Executive July 1, 2014 Jill Wechsler |
Pre-emption and States' Rights Pharma backs federal standards for compassionate use, drug importing, data transparency, and track-and-trace. |
Pharmaceutical Executive September 1, 2013 Jill Wechsler |
Biopharma Innovation in Trouble? Regulators, sponsors seek more productive research strategies. |
Pharmaceutical Executive December 1, 2013 |
FDA Pursues Delicate Balancing Act The Agency struggles to ensure access to needed medicines while minimizing potential risks, writes Jill Wechsler. |
Pharmaceutical Executive January 1, 2011 |
The Steep, Slow Climb A survey of leading experts reveals 2011's sobering reality and the trends that smart drugmakers will follow into the next decade. |
Pharmaceutical Executive October 1, 2011 Jill Wechsler |
"Representing" Healthcare to the Fullest Since coming to Congress about 35 years ago, Henry Waxman, Congressional Representative from Los Angeles, California, has been pivotal in shaping legislation on health and drug regulatory issues. |
Pharmaceutical Executive April 1, 2007 Jill Wechsler |
Washington Report: Medicaid Sets the Pace for Pharma Pricing Forget Medicare price negotiations. Pending changes in Medicaid drug-pricing formulas will put even more pressure on pharmaceutical prices. |
Pharmaceutical Executive February 1, 2011 Jill Wechsler |
Challenges, Changes, Commitments The Three Cs could be taxing on FDA resources as the new Congress brings stiffer oversight and leadership revisions to the agency |
Pharmaceutical Executive June 1, 2009 Jill Wechsler |
A Bigger, Bolder Agency FDA is seeking more resources to support compliance and oversight. |
Pharmaceutical Executive December 1, 2005 Jill Wechsler |
Washington Report: Big Production Drug manufacturing costs too much and is cumbersome to regulate. FDA's answer: Quality by design, which shifts the emphasis from testing the final product to building quality into the manufacturing process from the beginning. |
Pharmaceutical Executive September 1, 2005 Jill Wechsler |
Washington Report: Crawford Steps Up As FDA's new commissioner takes the reins, his key challenge is restoring trust in the agency. |
Pharmaceutical Executive August 1, 2008 Jill Wechsler |
Can Sentinel Save Drug Development? FDA's new sentinel system shows the pendulum swing toward safety won't swing back anytime soon. |
Pharmaceutical Executive July 1, 2012 Jill Wechsler |
Who Will Pay for New Drugs? Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies. |
Pharmaceutical Executive April 1, 2012 Jill Wechsler |
Shortages and Sunshine Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors. |