DID - Aug. 18, 2009 Issue

Vol. 8 No. 160

FDA Outlines Commissioner’s Office Reorganization

The FDA has outlined its reorganization of the Office of the Commissioner, realigning four deputy-level offices — the offices of chief scientist; administration; policy planning and budget, and foods.

The chief scientist’s office will now include the offices of counterterrorism and emerging threats, Critical Path programs, scientific integrity and science and innovation, according to a Federal Register notice to be published Aug. 18. The change will allow the agency to focus the science and research activities under the office of Chief Scientist Jesse Goodman, the former CBER director (DID, April 10, 2008).

The Office of Operations will be renamed as the Office of Administration and will be restructured to strengthen agencywide management programs, budget and shared services operations, as well as the office of the commissioner’s executive operations, the FDA says.

“The critical factor at the FDA is effective leadership at the top, which has been absent for a long time,” Ira Loss, senior health analyst with Washington Analysis, told DID.

The Office of Policy, Planning and Preparedness will be renamed the Office of Policy, Planning and Budget. Among other changes, an Office of Financial Operations will be created and the Office of Foods will be shifted from operations to report directly to the commissioner, the notice adds. 

The reorganization comes on the heels of other major changes at the FDA, as Hamburg recently outlined steps to make the agency’s enforcement operations more effective and timely (DID, Aug. 7). — April Hollis


FDA Reopens Comment Period on Transparency Initiative

Stakeholders have until Nov. 6 to submit comments on the FDA’s transparency task force ahead of a planned second public meeting this fall.

The agency reopened the comment period as planned to gather more information on ways in which it can make information on its activities and decisionmaking more accessible to the public while protecting confidential information, the agency says in a Federal Register notice to be published Aug. 18.

The task force announced in June is led by FDA Principal Deputy Commissioner Joshua Sharfstein and includes the agency’s center directors, associate commissioner for regulatory affairs, chief scientist and chief counsel (DID, June 3).

PhRMA recommends in comments submitted to the agency that the FDA improve its website, better explain regulatory actions to healthcare professionals and patients, and consider adding a prominent link to its home page explaining the drug approval process in detailed, consumer-friendly language. The agency collected 151 comments in the previous period. — David Belian


FDA to Treat Most Investigator Financial Disclosures as Confidential

The FDA will keep information received from clinical trial sponsors on investigators’ financial conflicts of interest confidential “in almost all cases.”

Clinical investigators subject to IND exemption regulations must provide sponsors with accurate information so the sponsors can disclose the conflicts to the FDA, if they exist, or certify that there are no conflicts, according to the notice to be published in the Federal Register Aug. 18.

If an investigator holds a proprietary interest in a drug or device undergoing a clinical trial, that fact “is already public information and therefore releasable,” the FDA says.

Otherwise, the FDA will consider releasing such information only when the investigator’s interests are clearly outweighed by questions of propriety. The agency believes that such cases will involve only a small subset of those clinical investigators, but did not return some calls on the matter.

Financial arrangements between sponsors and investigators that are problems include “generous grants to fund ongoing research, expensive laboratory equipment, retainers for ongoing consultation and honoraria,” the FDA says. “The agency is also aware of proprietary and equity interests of some clinical investigators in the tested products or in the sponsors of these products.”

When an investigator has a conflict, the sponsor must file a Form FDA 3455 disclosing completely and accurately any of the investigator’s financial arrangements, significant payments, proprietary interests and significant equity interests, as well as any steps taken to minimize the potential for bias.

One comment the FDA received in response to a 60-day notice seeking public response that was published in the Dec. 29, 2008, Federal Register raised the issue of the cost to sponsors of collecting investigator financial information. The agency says it “will undertake a new evaluation whether there are capital costs or operating and maintenance costs associated with this collection of information.”

The FDA estimates that 25 percent of drug and device applications require disclosure statements, which should take about four hours to prepare using Form FDA 3455. “As the applicant will be fully aware of those [potential conflicts of interest] and the steps taken to address them, describing them will be straightforward,” the agency says. — Martin Berman-Gorvine


Gilead Subpoenaed Over Ranexa Marketing

Gilead Sciences has received a subpoena from the HHS Office of Inspector General (OIG) requesting documents regarding the development, marketing and sales of its chronic angina drug Ranexa.

Ranexa (ranolazine) was developed and originally commercialized by CV Therapeutics, a company that Gilead acquired in April, Gilead says in a statement Friday.

The drug was first approved by the FDA in 2006 to treat patients with chronic angina who did not benefit enough from other treatments (DID, Jan. 31, 2006). Last November, the agency expanded the indication, approving it as a first-line treatment for chronic angina and adding a claim that the drug slightly reduces levels of hemoglobin A1C (DID, Nov. 12, 2008).

Neither Gilead nor the OIG responded to requests for comment by press time. — Martin Berman-Gorvine


Court: Ultram ER Patents Invalid in Win for Par Pharmaceutical

Par Pharmaceutical has won a court battle over a proposed generic of Ortho-McNeil’s Ultram extended-release (ER) that may permit it to market its formulation of the painkiller in the U.S.

The company has tentative FDA approval of the 100- and 200-mg strengths of the drug and intends to review its options with respect to its ANDA, Par says in an Aug. 17 statement.

Judge Kent Jordan of the U.S. District Court for the District of Delaware ruled Aug. 14 that the ’887 and ’430 patents owned by Purdue Pharma Products are invalid as obvious in light of prior art, according to court documents filed recently. Both patents expire in May 2014. This prior art reference includes the previously issued ’578 patent, according to the documents.  

Jordan issued the ruling despite finding Par had infringed claims of Purdue’s patents and that Par had failed to prove Purdue had obtained the patents through inequitable conduct, according to court documents.

Biovail Laboratories holds the NDA for drug, and Ortho-McNeil, a Johnson & Johnson subsidiary, markets it in the U.S. Biovail isn’t a party to the decision, as its claims were dismissed Nov. 10, 2008. Ortho-McNeil was dismissed from the action in a Dec. 3, 2008 order, according to court documents.

The decision could have an effect on Biovail’s Ultram revenue. The company recorded Ultram ER revenues of $37.2 million during the first half of the year, the company says in an Aug. 17 statement.

Canadian drugmaker Labopharm sells a once-daily tramadol product known as Ryzolt, which is marketed in the U.S. by Purdue. Although Ultram ER and potential generic equivalents aren’t automatically substitutable for Ryzolt, Labopharm believes that the launch of Par’s generic could affect Ryzolt sales, the company says in the statement.

Purdue will decide whether to appeal the court’s ruling. Labopharm is in discussions with Purdue to evaluate next steps in this matter, including a potential appeal of the decision, according to the company’s statement.

The plaintiffs originally brought the suit, Purdue Pharma Products L.P., et al. v. Par Pharmaceutical, Inc., et al., in May 2007. — Elizabeth Jones


EMEA Advice Requests to Be Submitted Electronically in October

Drugmakers seeking scientific advice from the European Medicines Agency (EMEA) will be required to submit requests electronically starting in October.

The EMEA’s Scientific Advice and Protocol Assistance program will accept advice requests on a CD or DVD from drugmakers who have not met with the agency before they make a submission starting Oct. 12, the agency says in a statement Monday.

For drugmakers who have had a pre-submission meeting with the agency, the new policy will begin Oct. 19. The scientific advice program helps sponsors resolve issues in which there appears to be insufficient or no relevant detail in established EU guidelines, guidance documents, draft documents, pharmacopeia monographs or draft monographs released for consultation, the EMEA says.

The program’s move to electronic-only submissions follows the EMEA’s implementation Aug. 3 of a policy requiring drugmakers seeking qualification of novel methodologies for drug development to submit applications on a CD or DVD only. — David Belian

Customer Service: Kim Williams
(888) 838-5578 • +1 (703) 538-7600
Editorial: David Grant
(703) 538-7600
Ad Sales: Matt Salt
(703) 538-7642
Content Sales: Alka Desai
(703) 538-7669

300 N. Washington St., Suite 200 • Falls Church, VA 22046-3431
Phone: (888) 838-5578 • +1 (703) 538-7600 • Fax: +1 (703) 538-7676

Reporters: David Belian, Martin Berman-Gorvine, April Hollis, Elizabeth Jones, Owen Skoler

President: Cynthia Carter; Publisher: Matt Salt; Editorial Director: David Grant; Executive Editor: Theresa Barry

Copyright © 2009 by Washington Business Information Inc. All rights reserved. Drug Industry Daily (ISSN 1541-6607), an executive briefing on the regulation of pharmaceuticals, is published daily, 250 issues, for $1,495. Photocopying or reproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher’s express written permission. Subscribers registered with the Copyright Clearance Center (CCC) may reproduce articles for internal use only. For more information, contact CCC at www.copyright.com or call (978) 750-8400. For site licenses for multiple users or to purchase multiple copies, contact Content Sales Manager Alka Desai at (703) 538-7669