Jill Wechsler is a veteran reporter specializing in federal health care and pharmaceutical issues.
Medicare 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 drug benefit has been a success.
FDA user fee legislation speeds drug approvals, addresses shortages, counterfeits
The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.
CER 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 care. This approach is gaining momentum from the Patient Centered Outcomes Research Institute (PCORI), which is poised to distribute some $120 million in coming monthsâ€”and nearly $400 million in 2013â€”to launch a range of CER projects.
Payers seek more comparative research documenting value and affordability of high-cost therapies
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 pondered strategies for convincing payers to cover the new life-saving drugs.
Health reform survives
In a complex decision, a slim majority of the Supreme Court upheld the constitutionality of the Affordable Care Act.
Congress moves promptly to finalize FDA user fees
House and Senate leaders announced final agreement June 18 on legislation that authorizes industry user fees to support FDA regulatory programs.
FDA 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 measure. Much of the work will be tackled by committee staffers who have been laboring over the legislative details for months. The aim is to bring the House and Senate leaders together in about 2 weeks to hash out the final language.
New 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.
FDA Commissioner Hamburg builds agency's capabilities for bringing new therapies to patients
In less than 1 full year at the helm of FDA, Margaret (Peggy) Hamburg has worked to reposition FDA as a public health agency able to ensure the safety and quality of the nation's food supply and medical products.
Generic drugs dominate market, look to expand into biologics
Generics makers have aggressively challenged drug patents before scheduled expiration, while brand-name manufacturers have delayed generic entry through 30-month stays, citizen petitions, and deals to "authorize" generic products that are less threatening to the brand.
Safety concerns slow new drug review and approval processes
FDA is struggling to implement a host of new drug safety policies and programs and still meet review time frames set by the Prescription Drug User Fee program (PDUFA).
FDA leadership promotes scientific integrity, quality standards
FDA officials are taking steps to erase the charges of incompetency and ineffectiveness that have plagued the agency for several years.
Global health concerns generate new therapies for home and abroad
Even before the emergence of the swine flu pandemic, biopharmaceutical companies were investing in vaccines and treatments for lethal diseases that plague much of the world. There is growing recognition that Americans and Europeans are vulnerable to infections from overseas, and that development of new medications is critical to ensuring public health.
Healthcare reform to shape drug coverage, costs, and R&D
With healthcare-reform legislation moving forward, insurers, providers, and pharmaceutical companies are keeping a sharp eye on policy proposals likely to affect coverage, costs, and benefits. Various constituencies in the healthcare community are supporting initiatives that will increase access to healthcare and make the nation's costly healthcare system more efficient and effective.
Healthcare reform requires a hard look at drug costs and savings
Among members of the new administration, congressional leaders, payors, and providers, many are eager to transform the nation's healthcare system to curb unnecessary spending and make coverage more fair and efficient. A chief problem is that the US healthcare bill keeps increasing faster than the rest of the economy, with little to show in the way of quality improvement.
Economic crisis will challenge Obama's health coverage expansion plans
During his campaign for the presidency, President-elect Barack Obama stated that all Americans have a right to healthcare and that he will expand coverage for the uninsured. Many voters cited healthcare as a key election issue; however, the need to address a rising unemployment rate and low economic growth may force Obama to seek more limited changes in the near future.
Conflicts of interest under investigation as policies begin to change
As conflicts of interest between academia and the pharmaceutical industry are again under investigation, several pharmaceutical companies and universities are beginning to change their policies on disclosures and funding.
Pharmaceutical marketing practices and generic drugs in the spotlight
Formulary committees, pharmacy benefit managers (PBMs), pharmacists, and physicians face increased scrutiny of their relationships with pharmaceutical manufacturers under a final fraud policy statement from the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS).
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