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HHS Looking for an Rx for Costly Clinical Trials

By Mari Serebrov
Washington Editor

As the cost of conducting clinical trials helps drive drug prices beyond the wallet of many U.S. patients, the Department of Health and Human Services (HHS) is looking for ways to streamline those trials.

The goal is to bring the cost down while ensuring the safety of drugs and speeding access to innovative therapies.

As part of that effort, consulting firm Eastern Research Group Inc. will analyze trial cost data to identify factors that delay or derail clinical studies. It also will help HHS assess the economic benefit of implementing policies encouraging more streamlined trials.

To get the necessary information for the analysis, HHS and ERG will use Medidata Solutions' databases, which contain information from more than 275,000 negotiated clinical site grants and nearly 9,000 outsourced R&D contracts.

The research is to be conducted over the next few months, with results expected by the end of the year, according to Medidata.

HHS isn't the only one looking at the cost of clinical trials.

The National Bureau of Economic Research is using Medidata's databases to develop a trendable cost index for trials, and the Pharmaceutical Research and Manufacturers of America is using the industry data to research the costs of post-approval trials.

The increasing cost of clinical trials has been cited as a big factor in the rising cost of drug development and as a force that's pushing down company valuations.

Not only has the cost of conducting a trial increased, but the size and number of trials required for some products have added to the expense. (See BioWorld Insight, Oct. 31, 2011.)

The development of Orexigen Therapeutics Inc.'s obesity drug Contrave (naltrexone HCl/bupropion) is a case in point.

After doing all the necessary pivotal and confirmatory trials, Orexigen was told it needed to conduct a cardiovascular outcomes trial involving nearly 10,000 subjects. That trial alone is expected to cost somewhere between $100 million and $120 million. (See BioWorld Today, Dec. 16, 2011 .)

PTO Proposes New Fees

While other agencies are setting user fees ahead of the Oct. 1 start of fiscal 2013, the Patent and Trademark Office (PTO) is revamping its whole fee structure in keeping with the America Invents Act (AIA).

That means setting or adjusting 352 patent fees – 94 of which apply to large entities, 94 to small entities, 93 to micro entities and 71 that aren't entity-specific. The proposed fees, published in Thursday's Federal Register, include a new 75 percent fee reduction for micro entities and expand the availability of the 50 percent fee reduction for small entities, providing a discount on more than 25 patent fees that currently don't qualify for a small entity discount.

The fees are at least 22 percent lower for a routine patent process than the current fee schedule, according to the PTO.

Despite all the discounts, the agency estimated that the fees will produce enough additional revenue to cut the patent pendency time by 12 months. Comments on the fees are due by Nov. 5.

The PTO proposed a number of fees earlier this year to fund new services that are to be implemented by Sept. 16 as part of the AIA.

Although it plans to finalize those fees within the coming months, it expects they will be replaced once the newly proposed fees are implemented.

Meanwhile, the SEC has set registration fees that will go into effect Oct. 1 . Fee rates applicable under Section 6(b) of the Securities Act and Sections 13(e) and 14(g) of the Exchange Act will be $136.40 per million. That's based on an estimate of the aggregate maximum offering price for fiscal 2013 of more than $3.3 trillion, the SEC said.

In addition, the FDA's new biosimilar and generic user fees, as well as increases in prescription drug fees, will go into effect Oct. 1. (See BioWorld Today, Aug. 2, 2012.)

Petition Leads to Lawsuit

Public Citizen Inc.'s patience with the FDA has worn thin.

Tired of waiting for a response to a citizen petition it submitted more than a year ago, the public watchdog filed a lawsuit seeking to force the agency to respond to its request to withdraw Aricept (donepezil hydrochloride) 23-mg tablets from the market.

The petition, filed in May 2011, also asked the FDA to add a warning to the labels for the 5- and 10-mg tablets of Aricept and generic donepezil about the increased toxicity associated with higher doses.

The request was based on conclusions from agency reviewers that the 23-mg dose has no greater efficacy than the lower doses but has more severe, and potentially life- threatening, side effects, according to the lawsuit filed this week in the District Court for the District of Columbia.

Manufactured by Eisai Co. Ltd. and marketed by Pfizer Inc., Aricept was approved, at the 5- and 10-mg dosages, in 1996 to treat Alzheimer's. A few months before Aricept's patent protection was to expire in 2010, the FDA approved the 23-mg tablets, extending the patent protection for another three years, Public Citizen said.

Last December, the FDA notified the group that it had yet to reach a decision on the petition, which it said raised "significant issues requiring extensive review and analysis by agency officials."

Public Citizen claimed the delay violates the Administrative Procedures Act, adding that "the pace of the FDA's decisional process is lagging unreasonably in light of the nature and extent of the public health interests at stake."

FTC Approves Novartis Order

The FTC approved a final order this week requiring Novartis AG to divest marketing rights for four topical skin care drugs to Tolmar Therapeutics Inc., of Fort Collins, Colo. The consent agreement resolves anticompetitive charges stemming from the Basel, Switzerland-based company's proposed $1.525 billion acquisition of specialty dermatology company Fougera Pharmaceuticals Inc., of Melville, N.Y.