Congress, regulators face reform challenges, funding issues in the year ahead
The political tensions wrought by last November's mid-term elections will play out in a number of situations affecting health plans and pharmaceutical companies this year.
View ArticleFDA faces congressional probes and more transparency and organizational changes
With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are contemplating broad federal budget cuts and much more aggressive oversight of...
View ArticleHealth system databases support comparative studies, quality assessment, and...
The active drug safety surveillance system being established by FDA promises to do more than obtain timely adverse event information on marketed medicines.
View ArticleHealth reform controversies pose new challenges for drug plans and healthcare...
There's growing uncertainty about how the Obama healthcare reform program will be implemented, and how proposed changes will affect biomedical product development and coverage of prescription drugs.
View ArticleFDA, NIH, pharma companies seek new strategies to spur drug development
Drug devleopment pipelines have shrunk; fewer new products are being approved for market; and pharma companies are scaling back R&D as patent expirations on blockbuster drugs reduce industry revenues.
View ArticlePolicy-makers move to curb drug abuse, diversion and disruptions to ensure...
The proper use of prescription drugs is central to a number of important regulatory and public policies issues now in the spotlight.
View ArticleDevelopment of biosimilars creates challenges for FDA, manufacturers
FDA is developing guidelines for documenting similarity and interchangeability of copycat versions of biotech therapies, a process that is drawing considerable scrutiny from a broad spectrum of...
View ArticleFDA maps strategy to deal with rising drug imports, counterfeiting, and other...
FDA officials recently acknowledged that its established system for ensuring the quality and safety of drugs and other medical products cannot cope with significant changes in today's global medical...
View ArticleNew user-fee renewal legislation will include new policies affecting...
The push has begun for new policies to "improve" the drug approval process as all sides gear up to reauthorize prescription drug user fees next year.
View ArticleGlobal health challenges spur development of vaccines at home and abroad
It's flu season again, which always focuses public attention on the reliablity and availability of the nation's vaccine supply.
View ArticleDrug shortages challenge the healthcare community, FDA, and pharmaceutical...
The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medicines to treat cancer, pain, and other serious conditions is drawing attention from the White House,...
View ArticleFDA promotes innovation, access to medicines while modernizing operations
FDA is under pressure to encourage medical product development, monitor an increasingly global supply chain, and accomplish everything with ever-tighter resources. In the last few years, Congress added...
View ArticleHigh Court to rule on health reform legality
The US Supreme Court, as expected, will decide if key provisions of the Obama administration's healthcare overhaul law violate the Constitution by exceeding the federal government's power to regulate...
View ArticleBudget crunch, political battles shape 2012 policy agenda
Election-year politics will color a range of legislative and policy developments affecting drug development, production, and reimbursement in the coming year, as efforts to reduce government spending...
View ArticleHealth reform promises expanded drug coverage through ACOs, exchanges,...
Last month, economists in the Department of Health and Human Services (HHS) reported a big slow-down in healthcare spending for 2010. Outlays rose only 3.9% to $2.6 trillion, largely because the...
View ArticleFDA user fee renewal addresses drug shortages, new drug development
Every 5 years, Congress is called on to reauthorize a series of user fees that support FDA oversight of drugs and medical products. The Prescription Drug User Fee Act (PDUFA) and similar measures...
View ArticleFDA unveils guidance for biosimilar development
After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.
View ArticleDrug abuse, counterfeits, and critical shortages illustrate need for secure...
The United States is caught in an epidemic of prescription drug overuse and abuse, and efforts to counter such activity are affecting drug distribution, prescribing, and oversight. Just as troubling is...
View ArticleFDA user fee legislation heads toward finish line
Legislation to reauthorize FDA user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise...
View ArticleNew models support comparative research, more nonprescription drugs
The drive for personalized medicine and greater patient involvement in treatment decisions demands more informative data on the effects and risks associated with drugs and medical products.
View ArticleHealth reform survives
In a complex decision, a slim majority of the Supreme Court upheld the constitutionality of the Affordable Care Act.
View ArticlePayers seek more comparative research documenting value and affordability of...
While scientists and biomedical researchers at the recent meeting of the American Society of Clinical Oncology (ASCO) applauded encouraging data on dozens of breakthrough cancer therapies, analysts...
View ArticleCER studies will shape coverage decisions
To reduce the money spent on treatments that don't work, health plans and payers are examining closely how Comparative Effectiveness Research (CER) can steer patients and providers to more appropriate...
View ArticleFDA user fee legislation speeds drug approvals, addresses shortages,...
The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.
View ArticleMedicare Part D plans control drug spending
The Medicare Part D prescription drug program has emerged as the poster child for how private plans can control costs while providing quality care. Even critics of health insurers acknowledge that the...
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