Washington Editor

WASHINGTON - Drug makers will face higher application costs in the coming government fiscal year, as the FDA last week unveiled an increase in PDUFA rates.

As of Oct. 1, the agency will charge $767,400 in application fees for a submission requiring clinical data, a $95,400 hike over the going rate. Additional application fees are climbing as well: It will cost $383,700 for an application not requiring clinical data or a supplement requiring clinical data, $264,000 for establishment fees and $42,130 for product fees.

The new prices, authorized under the third generation of the Prescription Drug User Fee Act, will remain in effect through Sept. 30 of next year. That law allows the agency to collect fees on drug and biological products, and the rates are to be established each year by the FDA so that revenues from each category will approximate the revenue levels established in the statute, after those amounts have been adjusted for inflation and workload.

In contrast, fees for medical device companies will go down next year. Also, rates in that industry are to be based on company size, with smaller firms paying less for applications.

The information was published in the Federal Register.

New Medicare Stroke Payments Climb

Medicare is expanding its stroke coverage, and in the process is better covering Genentech Inc.'s clot-dissolving tissue plasminogen activator (tPA) product. The new ruling stems from concern that stroke diagnoses were not sufficient to cover the use of tPA.

In examining stroke cases - classified under Medicare codes 14 and 15 - the agency compared cases that also included coding for tPA vs. stroke cases absent tPA coding. Cases with tPA proved more costly, not only because of the drug's cost, but also because the patients were less healthy and had, on average, longer hospital stays and more intensive services. So Medicare last week released its Diagnosis Related Group 559, defined as acute ischemic stroke with use of a thrombolytic agent, which will go into effect on Oct. 1.

In the end, Medicare will pay hospitals a significantly higher amount for stroke cases that use tPA. The agency will begin paying hospitals a base rate that is about $6,000 more per stroke case if tPA is administered; currently, it pays a flat rate of about $5,700 per case of stroke, regardless of whether the drug is administered.

Genentech, of South San Francisco, markets tPA as Activase, a recombinant product approved for treating heart attacks, acute ischemic stroke and acute, massive pulmonary embolism.

Pozen Sheds MT 100 Migraine Drug

Pozen Inc. is dropping MT 100 from its portfolio following an FDA panel meeting last week.

The agency's Peripheral and Central Nervous Systems Drugs advisory committee had decided that the migraine drug's risk of tardive dyskinesia would outweigh its benefits. That risk assessment, labeled as unquantified by the Chapel Hill, N.C.-based company, resulted from the association of one of the combination drug's components, metoclopramide, with the involuntary neurological movement disorder. More than a year ago, Pozen received a not-approvable letter from the FDA on its new drug application for MT 100. (See BioWorld Today, Aug. 5, 2005.)

Going forward, the company is focusing its efforts on filing for approval of Trexima, another migraine drug that has demonstrated greater efficacy without the metoclopramide risk associated with MT 100.

New Warnings, Indication On Cox-2 Drug

Pfizer Inc. and the FDA said an updated label on Celebrex (celecoxib) includes a boxed warning of the product's potential cardiovascular and gastrointestinal risks consistent with warnings for other prescription pain relievers, including older medicines such as ibuprofen and naproxen. The new labeling follows an FDA advisory panel meeting held earlier this year on all COX-2 selective products, as well as drugs of other related classes such as non-steroidal anti-inflammatory agents. (See BioWorld Today, Feb. 17, 2005.)

Celebrex's recommended osteoarthritis dose is 200 mg daily, and 200 mg to 400 mg per day for adult rheumatoid arthritis.

At the same time as the parties agreed on the new labeling, the FDA also approved a new use for Celebrex to treat ankylosing spondylitis. For managing that indication, arthritis of the spine, the drug's recommended dose is 200 mg daily, in one or two doses.