PHARMACY

Meningitis outbreak linked to compounding pharmacy spawns new proposed legislation

BY Michael Johnsen

ALEXANDRIA, Va. — Rep. Edward Markey, D-Mass., on Thursday announced plans to introduce legislation that would strengthen federal regulations of compounding pharmacies. The legislation is borne out of the recent meningitis outbreak linked to the New England Compounding Center, which is located in Markey’s district, that has drawn much criticism on how regulators oversee compounding pharmacies. According to Markey, the Verifying Authority and Legality in Drug Compounding Act will give the Food and Drug Administration clear, new authority to oversee compounding pharmacy practices throughout the country.

“Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory,” said Markey, a senior member on the Energy and Commerce Committee. “The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies."

The industry expressed mixed feelings over the proposed legislation. “We appreciate and agree with Rep. Markey’s interest in wanting to achieve the proper balance to promote patient health and allow for traditional pharmacy compounding services to continue, while addressing any entities illicitly manufacturing pharmaceuticals under the guise of compounding, as highlighted by the tragic meningitis outbreak," stated John Coster, SVP government affairs for the National Community Pharmacists Association. "The New England Compounding Center appears to have been engaged in inappropriately manufacturing medications and doing so without valid prescriptions," he said. “However, the proposed legislation also appears to create new overly broad requirements on traditional pharmacy compounding that could negatively impact both patients’ access to essential medications and the community pharmacists who provide them. As currently drafted, the legislation would grant new powers to an already stretched FDA to regulate traditional pharmacy compounding, and create new roadblocks for patients by requiring waivers for pharmacists to make medications that they have been making safely and effectively for decades."

The NCPA is currently reviewing the legislation and will submit comments to Markey, Coster noted. 

“This bill will save lives by ensuring that compounding pharmacies play by the rules that are essential to protect patients,” said Diana Zuckerman, president of the Cancer Prevention and Treatment Fund. “This month’s tragic meningitis outbreak from contaminated steroid injections was absolutely preventable. We call on Congress to work in a bipartisan manner to pass congressman Markey’s legislation, which is necessary to protect our families from these predictable, preventable tragedies.” 

The legislation has been endorsed by the Cancer Prevention and Treatment Fund, Jacobs Institute for Women’s Health, National Consumers League, National Research Center for Women & Families, Our Bodies Ourselves and Union of Concerned Scientists.

A copy of the VALID Compounding Act can be found here

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Reports: Generic extended-release drugs to get more attention from FDA

BY Alaric DeArment

NEW YORK – Some generic drugs may come under more scrutiny from the Food and Drug Administration amid reports that the generic version of a treatment for depression didn’t work as well as the branded version, according to published reports.

The New York Times reported that the FDA would look at companies making generic extended-release drugs after it received reports that patients taking Impax Labs’ generic version of Wellbutrin XL (bupropion) in the 300-mg strength was less effective than GlaxoSmithKline’s original version. Impax and Teva, which also makes generic bupropion, have stopped marketing the drug in that strength.

The FDA said that although the problem appeared to only affect that one strength of the drug, it would start to pay closer attention to how companies make generic extended-release drugs, according to the Times. The newspaper also quoted Generic Pharmaceutical Association president and CEO Ralph Neas as saying he supported the science behind the FDA’s decisions as well as continued development of that science.

 

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Global MS market to reach $19.5 billion in 2017, report finds

BY Alaric DeArment

FARMINGTON, Conn. – The global market for treatments for neurodegenerative disorders will exceed $20 billion before the end of the decade, according to a new report.

Global Information announced the availability of four research reports that analyze the global markets for treatments for syndromes of progressive ataxia and weakness disorders. According to GII, the global market for treatments was nearly $14 billion and is expected to reach $23.5 billion by 2017, after increasing at a five-year compound annual growth rate of 9.4%.

Key areas of growth include Friedrich’s ataxia, Gerstmann-Straussler-Scheinker disease, Machado-Joseph disease, progressive bulbar palsy, hereditary spastic paraplegia, hereditary neuropathies, multiple sclerosis and amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.

Treatments for progressive weakness syndromes — a category that includes MS — are expected to total nearly $14.6 billion this year and $22.8 billion by 2017; MS treatments are expected to reach $19.5 billion by 2017.

Treatments for dementia and movement disorders, such as Parkinson’s disease, are expected to reach $11.1 billion this year and $16.7 billion in 2017. 

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