PHARMACY

GPhA: Including provisions relating to biologics in TPP agreements is ‘premature’

BY Alaric DeArment

WASHINGTON — The country’s largest trade group for generic drug companies is concerned that the government’s negotiations on the Trans-Pacific Partnership agreement could hinder competition and access to generic drugs.

The Generic Pharmaceutical Association sent a letter to President Barack Obama Tuesday saying that provisions relating to intellectual property rights for biotech drugs should not be included in the TPP, a proposed regional trade agreement for the Asia-Pacific region.

The GPhA noted that while implementation of a regulatory approval pathway for biosimilars is ongoing at the Food and Drug Administration, significant disagreement remains about how the law should be implemented and whether further legislation is necessary.

“Given your administration’s position and the uncertainty surrounding the pathway’s implementation by [the] FDA, as well as the critical need to ensure access to safe and affordable medicines in global markets, it is premature to include provisions relating to biologics in any trade agreement,” GPhA executive director Bob Billings wrote in the letter.

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Poll: Most Americans believe oral contraceptive costs should be covered by insurance

BY Michael Johnsen

ANN ARBOR, Mich. — Many American consumers are in favor of oral contraceptive coverage by both private and government-subsidized health insurance plans, according to a Thomson Reuters-National Press Radio Health Poll released Friday.

"Our survey findings provide a benchmark for public sentiment on issues that are continually dividing lawmakers, businesspeople and healthcare professionals," said Raymond Fabius, chief medical officer at the healthcare business of Thomson Reuters.

The poll, which addresses public attitudes toward birth control pills, was developed by Thomson Reuters and NPR as part of a new monthly series designed to gauge attitudes and opinions on a wide range of healthcare issues. Poll results are reported by NPR’s Scott Hensley on the health blog Shots and on air.

The poll found that 77% of respondents believed private insurance should cover most or all cost of oral contraceptives, and 74% believed government-subsidized insurance plans should cover birth control pills.

Additionally, 78% favored federal government subsidies of birth control and other family planning services, excluding abortion, at government-funded clinics for low-income women.

Complete survey results are available here.

To date, Thomson Reuters and NPR have addressed a number of healthcare topics, gauging sentiment on generic drugs, vaccines, food safety and other issues. NPR’s reports on past surveys are archived at Shots.

Thomson Reuters also offers a library of poll results here.

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FDA OKs infant-specific dose of Creon

BY Alaric DeArment

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a new dosage of a drug made by Abbott for treating cystic fibrosis in infants, the drug maker said Tuesday.

Abbott announced the approval of an infant-specific dose of Creon (pancrelipase) delayed-released capsules to treat exocrine pancreatic insufficiency due to cystic fibrosis.

Most infants with the disease require small doses of pancreatic enzyme replacement therapy with every feeding, but parents or caregivers previously had to open a capsule and measure out a portion of the contents. The new capsule will allow them to provide a more precise dose.

“We know that the need for consistent, precise dosing of pancreatic enzyme replacement therapy is critical for infants and children living with cystic fibrosis,” Abbott VP global pharmaceutical development Eugene Sun said. “This approval means that Creon will now be available in four dosing options, including both the lowest and highest dosage strengths available to patients in the United States, providing improved dosing titration options and flexibility into adulthood.”

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