Federal law enforcers are looking hard at pharmaceutical manufacturers that put consumers at risk by cutting corners on product quality and safety and violating current good manufacturing practices (cGMPs). The Department of Justice (DOJ) is “taking an especially hard look” at situations that compromise drug safety, identity and quality, explained DOJ deputy assistant attorney general Maame Ewusi-Mensah Frimpong at this week’s CBI Compliance Conference in Washington, D.C. Read more »
In the dog-eat-dog world of federal deficit reduction in the US, there seems to be one health-related spending cut with broad bi-partisan support: require drug companies to give the federal government “a better deal on medications for low-income people on Medicare.” Nearly 70% of respondents back this strategy, according to a survey sponsored by the Kaiser Family Foundation (KFF), the Robert Wood Johnson Foundation and the Harvard School of Public Health. That’s far more than the mere 32% who want to raise Medicare premiums or the 26% who support a higher Medicare eligibility age (67, up from 65 years). Read more »
A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world. The credit goes to public health authorities and medical experts who challenged a provision blocking production of vaccines with the preservative thimerosal, the formulation necessary for efficient vaccine distribution in developing countries. Banning thimerosal in vaccines “would be a tragedy” that put millions of children at risk, stated GAVI (Global Alliance for Vaccines & Immunization) director Seth Berkley in the New York Times (Jan. 17, 2013). Read more »
Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in the pipeline globally, many for untreated diseases and life-threatening conditions. The promise is that this more robust pipeline will lead to more new critical therapies for patients. Read more »
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.
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.