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Backlog of ANDAs could be alleviated with passage of generic drug user fee act
Congressional approval of the bipartisan Generic Drug and Biosimilars User Fee Act could eliminate 90% of the backlog of Abbreviated New Drug Applications by 2017, FDA official Russell Wesdyk, BS, MBA, said in a presentation last month.
Congressional approval of the bipartisan Generic Drug and Biosimilars User Fee Act could eliminate 90% of the backlog of Abbreviated New Drug Applications (ANDAs) by 2017, FDA official Russell Wesdyk, BS, MBA, said in a presentation last month.
Currently, more than 2,000 ANDAs are awaiting approval, according to FDA data.
The legislation also will guarantee consumers “timely access to safe, affordable, and high-quality generic drugs,” Wesdyk, scientific coordinator in FDA’s Office of Pharmaceutical Science, told Formulary in a follow-up interview.
The bill was introduced in the House in February by 2 Republicans and 2 Democrats after months of negotiations between industry and FDA representatives. It appears to have little opposition.
The bill would require generic drugmakers to pay $1.5 billion in user fees over the next 5 years. The money would allow FDA to hire and train additional staff for inspections and reviews. Industry leaders feel they would make up the money by getting the new generic drugs and biosimilars to market more quickly.
“The application process would be more efficient and eliminate the backlog that we have now,” Wesdyk said.
He emphasized, however, that a more efficient process didn’t mean that it would be rushed. The 10-month review cycle would remain in place.
“A generic review can be just as complex as the review of a new drug,” Wesdyk said.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
