Recent change likely to boost drug coverage by plans, but with variation in formularies.

Health plans offering coverage to individuals and small companies are more likely to cover multiple drugs in each class or category under revised regulations proposed by the Department of Health and Human Services in November. A key change in rules to implement the Affordable Care Act (ACA) is regarded as a big win for pharma, as some 20 million Americans are expected to enroll in plans sold through exchanges, greatly expanding the market for prescription drugs. Read more »

Efforts to repeal the Affordable Care Act (ACA) died on election day, as President Barack Obama won a second term in the White House and the Democrats maintained control of the Senate. House Republicans will continue to challenge various provisions in the health care legislation, but key provisions for pharmaceutical companies, such as rebates on drugs for seniors in the Part D coverage gap and authorization for biosimilars, are unlikely to change. Read more »

A national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stiffer FDA regulation of these activities. Last week, the Centers for Disease Control and Prevention (CDC) reported 7 deaths and 91 ill, with the numbers rising daily. Thousands of individuals have been exposed to some 17,000 vials of methylprednisolone acetate produced by the New England Compounding Center (NECC) and shipped to 23 states in recent months. Read more »

The heavy buzz at the recent fall technical conference sponsored by the Generic Pharmaceutical Association (GPhA) involved proposals for reorganizing the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER). A few weeks ago, CDER director Janet Woodcock announced plans to elevate the Office of Generic Drugs (OGD) to “super office” status, pulling it out of OPS so that its director Greg Geba would report directly to her. Read more »

Even though Congress authorized both existing and new user fees for the Food and Drug Administration several months ago through the FDA Safety & Innovation Act (FDASIA), efforts to cut the federal deficit raises questions about how those fees will be collected and used in the coming year. FDA, along with the rest of the federal government, is operating under a Continuing Appropriations Resolution (CR) through the end of March 2013. That keeps funding at 2012 levels and puts many new initiatives on hold until Congress fully approves 2013 appropriations bills.

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More funds sought to provide effective medicines to more patients, even to prevent HIV infection.

Prominent scientists and political leaders at the International AIDS Conference in Washington, D.C., in late July were optimistic for the first time about bringing an end to the global AIDS pandemic. Medical advances over the past 30 years have led to development of nearly 30 effective antiretroviral (ARV) medicines, along with better methods for identifying infected individuals and for managing their care. New research indicates that ARVs can prevent HIV infection, which promises to reduce disease transmission and slow the spread of AIDS around the world—and also expand demand for AIDS therapies.

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The main result of the Supreme Court decision upholding the Affordable Care Act (ACA) is that it ends all the rampant speculation and uncertainty about the future shape of the U.S. health care system. Now health care providers, insurers, medical products makers and government agencies can move forward with the complex process of establishing new programs and policies to expand coverage to millions of Americans. Patients can expect more coverage options and improved access to care, including prescription drugs.

The much-anticipated ruling produced an audible sigh of relief from the health care industry, even those parties that would have preferred to see much of the program disappear. For pharma and biotech companies, the decision means that the Food and Drug Administration can continue to implement the new biosimilars program and that industry will continue to pay higher Medicaid rebates and provide discounts to Medicare patients who reach the Part D doughnut hole.

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Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans.

House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support FDA regulatory programs. The bipartisan measure moved through Congress quickly with an eye to avoid getting tangled up in fallout from the imminent Supreme Court decision on health reform, as well as election-year politicking. The FDA Safety and Innovation Act (S. 3187) reauthorizes the Prescription Drug User Fee Act (PDUFA), renews user fees for medical devices and establishes new fees for oversight of generic drugs and for future biosimilar therapies. Read more »

Problems that lead to shortages, recalls are much more damaging than a few lost lots, say industry and FDA experts.

Are pharmaceutical manufacturers really serious about ensuring the quality of their medicines? And do they recognize that cutting corners on controls and quality management can be tremendously costly in the long run?

Those questions dominated the recent conference on “Redefining the ‘c’ in cGMP,” co-sponsored by FDA and ISPE (International Society for Pharmaceutical Engineering). The ongoing wave of serious drug shortages and recalls, together with rising pressure on pharma companies to cut costs, has elevated concerns about lax oversight of supply chains and outsourcing arrangements. Read more »

House & Senate leaders aim to resolve the many differences by end of June.

Legislation to reauthorize Food and Drug Administration 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 two weeks to hash out the final language. Read more »