Prominent Cardiologist Hammers the FDA: Insufficient Funding Compromises the Science of Drug Approvals


Robert Henry: Our editorial focus is on balancing the clinical, business, and regulatory criteria that guide the US healthcare system. As a new administration is taking over, we would like to ask you what you think those involved in healthcare, especially payers, can expect from this new environment.

Dan Mendelson: The new administration will look at the relationship between health plans and the government in a fundamentally different way from the previous administration.

Health Policy in the New Administration

The cost of employee health coverage continues to grow faster than inflation,1 putting additional economic pressure on employers and raising critical questions about how best to provide health benefits while ensuring optimal employee health and productivity. As a result, employers have grown increasingly important in benefit design decisions—decisions that ultimately determine beneficiaries' access to medical products and services.

Cost-Shifting—Where Does It Stop?

Cardiovascular (CV) disease (CVD) is the primary cause of mortality among men and women in the United States. An estimated 80.7 million American adults (1 in 3) have 1 or more types of CVD; of these, about 47% are estimated to be 60 years or older.1 From an employer’s perspective, the economic burden of CVD has grown steadily over the past decade, fueled by rising medical costs coupled with the indirect costs associated with CV morbidity and mortality.

Employer-Based Wellness Initiatives: Lifestyle Modifications Insufficient in Employees at High Risk for Cardiovascular Disease

Methicillin-resistant Staphylococcus aureus (MRSA) refers to isolates that are resistant to ß-lactam antibiotics (including penicillins and cephalosporins).1 According to the Clinical and Laboratory Standards Institute (CLSI), MRSA is defined as isolates with a methicillin minimum inhibitory concentration (MIC) ≥4 µg/mL; however, S aureus already is considered nonsusceptible to oxacillin if the MIC is >2 µg/mL.2

Prevention and Control of Methicillin-Resistant Staphylococcus aureus

While the market share of small-molecule generics continues to expand—now at 67% of all prescription drugs dispensed in the United States, according to the Generic Pharmaceutical Association (GPhA)1—the issue of biogenerics (or biosimilars, or biologics follow-on) remains unresolved.


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