Drug Industry Daily - Aug. 9, 2010 Issue

Vol. 9 No. 153

FDA Projects Decrease in NDA and BLA Submissions for Fiscal 2010

A decrease in fee-paying drug and biologic applications in fiscal 2010 could mean a slower regulatory pathway for drugmakers.

The FDA is expecting about 117 fee-paying full application equivalents (FAEs) this fiscal year, which represents a 16 percent decrease from last year, when it received 140 FAEs, the agency says in an Aug. 4 Federal Register notice.

Despite a 10 percent hike in PDUFA (Prescription Drug User Fee Act) fees expected to hit drugmakers Oct. 1, the agency will experience a decrease in revenue. That could affect the FDA’s critical path initiative, designed to improve regulatory science and the approval pathway for drugs, Peter Pitts, president of the industry-sponsored Center for Medicine in the Public Interest, told DID Friday (DID, Aug. 4).

“The FDA is severely underfunded even with increase in PDUFA fees,” Pitts said. “A drier pipeline freezes things where they are right now.”

One reason for the decrease in submissions could be the rising cost of scientific and clinical research for new drugs, he noted.

But Andrew Emmett, director of science and regulatory affairs at the Biotechnology Industry Organization, said there may be no clear explanation for the decline. “I don’t think there is any one driving factor that is reducing or increasing application volume,” he told DID. “It’s just natural variability.”

The FDA appears to be losing the most revenue from submissions requiring clinical data. Of 59 applications, 17 were either exempt or had their fees waived, bringing the total number of fee-paying applications to 42 in the first nine months of fiscal 2010.

In contrast, during the same period in fiscal 2009, the agency received around 88 applications requiring clinical data. Of those, roughly 32 were fee-exempt or waived, for a total of 56 fee-paying applications, the FDA says.

In total, the agency received 88 fee-paying submissions in the first nine months of fiscal 2010 versus 106 over the same period in the prior fiscal year.

The notice outlining the new fees can be found at http://www.fdanews.com/ext/files/FDA_feenotice_080410.pdf. — Virgil Dickson


Drugmakers Call for FDA Performance Goals as Generic User Fee Meeting Set

As the FDA lays the groundwork for a generic drug user fee program, drugmakers are calling on the agency to set performance goals as part of the plan to reduce the backlog of pending ANDAs.

The agency is set to hold its first public meeting on the topic next month and intends to ask for stakeholders’ opinions on issues including how a generic user fee program should be structured and what the fees should be used for, according to a notice published Monday in the Federal Register.

The FDA is also seeking input on how such a program should differ, if it all, from the existing user fee program for prescription drugs and if performance goals should be set for the agency.

That issue is likely to receive strong support from generic-drug makers, which have called on the FDA to reduce its ANDA logjam. The agency acknowledges its backlog has now reached more than 2,000 applications (DID, Feb. 19).

The FDA says that despite increasing productivity on its part, the number of generic applications it receives has been steadily increasing, and it needs the revenue user fees would bring to hire more staff and improve its review systems.

The Generic Pharmaceutical Association (GPhA) has been generally supportive of the fees, but wants to ensure the FDA develops “a meaningful program with measurable results,” Lorrie McHugh, a spokeswoman for GPhA, told DID Friday.

“During its negotiations with the brand industry, FDA granted the brand companies specific performance goals in exchange for an investment of resources,” GPhA says. “The generic industry should receive similar assurances.”

Before a user fee program can even be established, the agency must first get approval from Congress. While legislation authorizing the FDA to impose the fees has not yet been introduced, negotiations are slowly moving forward and there is a growing sentiment that a bill will be enacted next year, Kurt Karst, an attorney with Hyman, Phelps & McNamara, said.

In the FDA’s fiscal 2011 budget request, the agency proposed imposing $38 million in generic user fees, saying they would be used over five years to complete reviews for about 80 percent of ANDAs within 12 months of receiving them (DID, June 7).

The FDA’s public meeting on generic user fees is scheduled for Sept. 17 in Rockville, Md. The meeting notice can be found at www.fdanews.com/ext/files/2010-19537_PI.pdf. — David Belian


Bill Would Expand Priority Review Vouchers to Rare Pediatric Diseases

Sponsors of drugs for rare pediatric diseases could be eligible for the FDA’s priority review voucher program under a bill introduced by Sens. Sam Brownback (R-Kan.) and Sherrod Brown (D-Ohio).

The program currently offers sponsors of certain tropical disease drugs a voucher that can be used toward priority review for a subsequent human drug application.

The Creating Hope Act of 2010, S. 3697, announced last week, follows Brownback’s appearance before a Senate subcommittee in June where he called for more extensive development of orphan drugs (DID, June 28)

Sponsors also would have a process to request rare pediatric disease treatment designation when asking for orphan disease status or fast-track designation. However, requesting the designations would not be a prerequisite to receiving a priority review voucher, the legislation says.

While there is no limit on the number of times a priority review voucher may be transferred or sold before it is used, the act would add new notification requirements, timelines and user fee procedures for transfers.

The bill has been referred to the Senate Committee on Health, Education, Labor, and Pensions. — April Hollis 


AstraZeneca Sales Aid for Seroquel Draws FDA Untitled Letter

The FDA has cited AstraZeneca for a “misleading” Seroquel XR physician sales aid because the company claims the drug can achieve remission in major depressive disorder (MDD), but that claim is not backed by clinical studies.

The sheet misleadingly suggests that the antipsychotic Seroquel XR (quetiapine fumarate) plus an antidepressant allows patients to better achieve remission versus an antidepressant alone, according to the letter from the FDA’s Division of Drug Marketing, Advertising and Communications.

This has not been demonstrated by substantial evidence or substantial clinical experience, the July 29 letter, posted Aug. 4 on the FDA website, adds.

Studies referenced by the claims are not considered substantial evidence supporting claims of remission, as remission was not specified as a primary or key secondary measure.

Further, six weeks is not a long enough period to adequately assess remission, and there is no regulatory definition or criteria on how to define remission in MDD, the FDA says.

The sheet also presents a case study of a patient who is still experiencing unresolved MDD symptoms, including sadness and loss of interest. This presentation misleadingly suggests the drug alleviates the specific symptoms of sadness and loss of interest, the letter says.

The sheet also omits material information on a number of risks associated with Seroquel XR, including neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, and potential for cognitive and motor impairment. For example, while the sheet discusses the risk of tardive dyskinesia, it fails to state that the syndrome can develop after relatively brief treatment periods at low doses, although this is not common.

AstraZeneca is taking steps to address the contents of the letter and update its promotional material as appropriate, spokeswoman Laura Woodin told DID Friday.

The letter is available at www.fdanews.com/ext/files/UCM221315.pdf. — April Hollis


Daiichi, Apotex Reach Settlement in Evoxac Patent Case

Apotex will be able to introduce a generic version of Daiichi Sankyo’s dry-mouth treatment Evoxac in the fourth quarter of 2012 following a settlement in a patent infringement case.

The settlement, brokered last week, will resolve a case brought by Daiichi in 2009 in a Delaware federal court after Apotex filed an ANDA to market its generic of Evoxac (cevimeline HCl).

Evoxac is indicated for the treatment of the symptoms of dry mouth in patients with Sjogren’s syndrome, a condition that affects the immune system and causes dryness of certain parts of the body, such as the eyes and mouth.

Apotex’s ANDA for generic Evoxac included a Paragraph IV certification challenging the validity of Daiichi’s ’821 patent on the drug. As part of the settlement, Apotex has received a license to the ’821 patent, which expires in July 2013, Daiichi says.

Apotex did not respond by press time to a request for comment on whether it will have a period of marketing exclusivity for its generic Evoxac.

Daiichi had been seeking an injunction preventing Apotex from selling its generic version of the drug before the expiration of the ’821 patent, as well as unspecified damages. — David Belian

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