Jill Wechsler

The hope is that more biosimilars will lead to more access and more affordable medications, but biosimilar uptake is lagging. Here’s why and how FDA hopes to fix it.

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.

The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.

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 months—and nearly $400 million in 2013—to launch a range of CER projects.

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.

In a complex decision, a slim majority of the Supreme Court upheld the constitutionality of the Affordable Care Act.

House and Senate leaders announced final agreement June 18 on legislation that authorizes industry user fees to support FDA regulatory programs.

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.

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.

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.

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.

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 officials are taking steps to erase the charges of incompetency and ineffectiveness that have plagued the agency for several years.

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.

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.

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.

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.

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.

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).