PHARMACY

Expect flurry of legislative, provider activity on heels of new Calif. bills

BY Antoinette Alexander

Three bills that were introduced in California would recognize pharmacists as healthcare providers and would enable pharmacists, nurse practitioners and optometrists to practice to the full extent of their education and training.

The reality is that industry observers can expect to see more states considering similar measures as they all prepare a roadmap to lower costs by allowing pharmacists and NPs to practice at the top of their professions.

In fact, as previously reported by Drug Store News, lawmakers and other officials are taking notice and according to survey findings, so are HMOs. For example, the survey found that 75% of HMOs credential nurse practitioners as primary care providers, an increase over previous years. As the survey stated, there needs to be 100% credentialing in order “for the healthcare system to be ready for the huge influx of new patients in 2014. … All nurse practitioners must be able to practice to, and be compensated for, the full scope of their ability.”

The reason why this is critical is quite clear. First of all, there’s healthcare reform that will put roughly 30 million uninsured Americans into the coverage rolls come 2014, and then there’s the physician shortage in this country. It is estimated that the primary care physician shortage will reach about 60,000 by 2015.

According to numbers provided by the Convenient Care Association, as few as 2% of medical students coming out of U.S. medical schools intend to pursue a career in general primary care. Also, between 30% and 60% of patients of convenient care clinics — which are typically staffed by nurse practitioners — reported not having a primary care physician. Plus, as many as 40% of convenient care clinic patients said they would have sought costlier care or would have foregone care completely if there had not been a convenient care clinic available.

One can also expect a flurry of provider activity as private equity firms continue to invest against healthcare solutions and more new players piloting new alternatives hit the radar screen.
 

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Dr. Reddy’s launches generic acne drug

BY Alaric DeArment

HYDERABAD, India — Dr. Reddy’s has launched a drug for treating acne, the company said Friday.

The Indian generic drug maker announced the launch of Zenatane (isotretinoin) capsules in the 20-mg and 40-mg strengths. The drug is a therapeutically equivalent generic version of Roche’s Accutane. The Food and Drug Administration also approved the drug in the 10-mg strength.

Various versions of the drug had sales of about $309 million during the 12-month period that ended in January, according to IMS Health.

 

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FDA proposes regulations for meetings between agency, biosimilar makers

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

The agency’s Center for Drug Evaluation and Research announced Friday the release of draft guidance titled "Guidance for Industry: Formal Meetings Between the FDA and Biosimilar Biologic Product Sponsors or Applicants." The agency said the purpose of the guidance was for comment purposes only, and it did not reflect current regulations. An abbreviated approval pathway for follow-on biologics was enacted as part of the Patient Protection and Affordable Care Act of 2010, but regulations have yet to be finalized.

The FDA said the regulations were needed to ensure efficient, consistent procedures for meetings between the agency and drug makers, whether they take place face to face, via teleconference or video conference.

The draft guidance proposes five different types of meetings: Biosimilar Initial Advisory meetings, which discuss the feasibility of a proposed product; Biologic Product Development Type 1 meetings, to discuss issues like clinical holds, special protocols and safety issues; BPD Type 2 meetings, to discuss specific issues such as proposed study designs or study endpoints; BPD Type 3 meetings, which are in-depth data review and advice meetings; and BPD Type 4 meetings, to discuss the format and content of a product application.

 

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