PHARMACY

Pallone calls for user fees to fund overseas inspections

BY Drew Buono

WASHINGTON While some members of the medical device industry are opposed to the Food and Drug Administration receiving additional funds from user fees, one lawmaker believes it is essential.

The FDA’s need is “so great, there is going to be a need for user fees in addition to whatever is appropriated,” said Rep. Frank Pallone, D-N.J., chairman of the House Energy and Commerce Committee’s Health Subcommittee, at a hearing last week.

A draft bill concerning foreign inspections, co-sponsored by Pallone and Reps. John Dingell, D-Mich. and Bart Stupak, D-Mich., is aimed at preventing imports of unsafe products. The draft requires the FDA to inspect all overseas device-manufacturing plants once every two years instead of continuing its risk-based approach.

AdvaMed president and chief executive officer Stephen Ubl testified at last week’s hearing, saying inspections are a core function of the FDA and funding should come from appropriations, not industry fees. The draft would impose an additional facility registration fee and a $10,000 importer registration fee.

“Many of our members, particularly small companies, do not have foreign facilities, yet through their fees they would effectively subsidize inspection of foreign companies exporting their products to the U.S.,” AdvaMed said.

The bill is expected to move to markup soon, according to Pallone.

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PHARMACY

Santen completes Phase III testing of eye drug

BY Alaric DeArment

NEW YORK Inspire Pharmaceuticals announced Friday a $1.25 million milestone payment from Japan-based company Santen Pharmaceutical for the completion of Phase III testing of the eye drug diquafosol tetrasodium, also known as DE-089. The two companies have a collaborative agreement to develop the drug.

DE-089 is designed to treat such eye-surface diseases as dry eye. Santen expects to file for marketing approval in Japan by June, and also plans to market the drug throughout Asia. Pending approval of DE-089 by regulatory agencies, Santen will market the drug while Inspire will receive royalties on net sales.

New York-based Inspire discovers, develops and commercializes ocular and respiratory drugs. Santen specializes in ocular and anti-rheumatic drugs and had headquarters in Osaka, Japan.

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Salix receives FDA approvable letter for Balsalazide colitis treatment

BY Alaric DeArment

RALEIGH, N.C. Salix Pharmaceuticals has received an approvable letter from the Food and Drug Administration for its ulcerative colitis drug Balsalazide Tablet NDA, the company announced May 16. The drug is designed to treat mild-to-moderate active ulcerative colitis in patients 18 years and older. The disease causes ulcers in the lining of the rectum and colon.

Salix has headquarters in Raleigh, N.C., and specializes in drugs to treat gastrointestinal disorders. The company markets such drugs as Colazal (balsalazide disodium) capsules 750 mg, Xifaxan (rifaximin) tablets 200 mg, Osmoprep (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) tablets and Moviprep (PEG 3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution.

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