Drug Industry Daily - Dec. 13, 2010 Issue

Vol. 9 No. 240

J&J Recalls Rolaids for Metal, Wood Particles

Johnson & Johnson (J&J) is adding to its string of consumer product recalls, this time recalling 118 lots of various Rolaids products after consumer complaints of foreign materials, including metal and wood particles. 

The company’s investigation found a third-party manufacturer might have introduced the materials during manufacturing processes, J&J said Thursday. Spokeswoman Bonnie Jacobs told DID the company could not provide additional details on the situation.

While the investigation is ongoing, the company has suspended production of the products — Rolaids Extra Strength Softchews, Rolaids Extra Strength Plus Gas Relief Softchews and Rolaids Multi-Symptom Plus Anti-Gas Softchews — until corrective actions have been implemented.

The recall involves all lots of those products distributed in the U.S., although the company says the risk of serious adverse health consequences is remote.

J&J’s consumer products business has already seen several regulatory actions this year as its subsidiary McNeil Consumer Healthcare has had multiple recalls of OTC products and has come under FDA and congressional scrutiny (DID, Sept. 29).

“This most recent recall reinforces the [House Committee on Oversight and Government Reform’s] ongoing investigation surrounding the safety protocols in place at J&J’s facilities and how the FDA is managing food and drug safety,” Kurt Bardella, spokesman for Committee Chairman-designate Rep. Darrell Issa (R-Calif.), said Thursday.

Issa has been vocal about the need to examine the FDA’s bureaucracy and its relationship with regulated industry, Bardella adds. “The Committee is in the process of and will continue to seek answers from J&J and the FDA.” — April Hollis


FDA Saved From Federal Budget Freeze Initiative

Federal funding for the FDA could increase to $3.71 billion, including user fees, under fiscal year (FY) 2011 appropriations that passed the House 212–206 last week.

Not including user fees, the FDA will receive $2.5 billion in federal funds, a 7 percent increase from 2010.

The increase would come as Congress cuts many other federal programs in an effort to shrink the federal deficit. The FDA was spared from this fate as the additional resources are needed to protect the public from unsafe food and medical products, the House Appropriations Committee says in a summary of the bill.

“FDA will increase safety inspections for food, drugs, and medical devices,” the lawmakers say. “Strengthening FDA is critical because approximately 20 cents of every dollar spent by the American consumer is on an FDA-regulated product.”

The FDA is taking a cautious wait-and-see approach to the news.

“We are awaiting Senate action,” spokeswoman Karen Riley told DID Friday. “If that occurs, FDA will be able to collect up to the planned FY 2011 levels.”

Until then, the agency will follow continuing resolution rules, which allow it to spend at 2010 levels.

CDER could receive $963 million, which is more than the $850 million the FDA had requested for the center for 2011. When it requested additional funds, the center had said it would use the increase to hire 133 full-time equivalent (FTE) employees to grow to 3,214 FTEs (DID, Feb 2).

CBER could get $328 million, up from the $283 million it had requested. The biologics and blood center had said the money would go toward hiring an additional 24 FTEs, for a total of 651.

FDA advocacy groups are looking at the allotment cautiously.

“At a minimum, the president’s request will allow some program growth,” according to the Alliance for a Stronger FDA. “It will not, however, come anywhere near covering the amount by which FDA’s responsibilities and commitments have grown over the last year.”

Earlier this year, the FDA requested a $4.03 billion budget for fiscal 2011, a 23 percent increase, mostly from user fees, over the agency’s current budget.

The funding act is available at www.rules.house.gov/111/LegText/111_fullyearcr.pdf. — Virgil Dickson


FDA’s Temple Warns: Avandia Decision Likely to Set Precedent

As drugmakers continue to grasp implications of the FDA’s decision to severely restrict access to GlaxoSmithKline’s diabetes drug Avandia, an agency official is warning that the decision is likely to serve as a precedent for future FDA actions.

In Avandia’s (rosiglitazone) case, the FDA ultimately decided that concerns about cardiovascular risk associated with its use were not clear enough to justify pulling it from the market entirely. However, it was clear to FDA officials that the drug was more risky to patients than Takeda’s competing diabetes drug Actos (pioglitazone), Robert Temple, CDER’s deputy director of clinical science, said Friday at the FDA/CMS Summit in Washington.

The final result was to make Avandia available to new patients only if they are unable to achieve glucose control on other medications and cannot tolerate Actos (DID, Sept. 24).

The agency’s decision should serve as a wake-up call to drugmakers with products showing greater safety signals than other drugs in the same class, Temple said.

“If a member of a class has a side effect that other members of the class don’t have, that drug’s in trouble,” Temple said. He cited as examples Avandia and Pfizer’s withdrawn pain drug Bextra (valdecoxib), which caused life-threatening skin reactions in some patients. “Drugs like that are going to disappear,” he noted.

Temple, however, denied that the FDA is increasing the number of drugs it pulls from the market, saying, “the rate of actual withdrawals is the same as it has always been.”

For products still in the premarket stage, though, Temple acknowledged that the FDA is facing difficulty in meeting user fee action goal dates and heeding drugmakers’ requests for more frequent meetings with the agency to discuss the FDA’s drug development requirements.

Those complaints have been among the most consistent themes put forth by industry in recent meetings with the FDA ahead of the planned 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA).

The drug development meetings in particular are a positive thing, Temple said, but are much more productive when they are done before an application for a product has been filed.

“The most open meetings are the ones that occur during development when nobody’s got anything at stake yet,” Temple said. “Once an application is in it’s very hard to have informal negotiations.”

Still, there is evidence that the FDA may be taking note of industry’s concerns. At the most recent PDUFA meeting, the agency put forth a proposal for a late-stage meeting that would occur after the primary and secondary reviews of an application and would include the presence of an FDA signatory authority (DID, Dec. 8). — David Belian


Pfizer Withdraws Ex-US PAH Treatment Thelin

Pfizer is voluntarily withdrawing its NDA for pulmonary arterial hypertension (PAH) treatment Thelin, pulling it off the market in Australia, EU and Canada, and halting worldwide clinical trials for the drug due to the risk of liver injury.

Since 2006 Encysive Pharmaceuticals, purchased by Pfizer in 2008, has been trying to get Thelin (sitaxsentan) approved by the FDA. Despite receiving three approvable letters that asked for more clinical trials and questioned the compound’s efficacy, the company has an NDA on file with the FDA (DID, March 24, 2008).

The company will continue discussions with the agency regarding voluntary withdrawal of the NDA, Pfizer spokesman Curtis Allen told DID Friday.

Pfizer has sold Thelin in the three ex-U.S. markets since 2007. Sales for the first nine months of 2010 were $44.4 million.

Pfizer markets Bosentan (sildenafil) in more than 47 countries for PAH and is developing terguride, an oral serotonin receptor antagonist in Phase II.
 — Molly Cohen


Watson Gets Untitled Letter for Bathroom Stall Gelnique Ad

Watson Pharmaceuticals has received an untitled letter for misleading and unsubstantiated claims on a bathroom stall ad for its overactive bladder drug Gelnique.

The ad minimizes risks by showing efficacy claims in large, colorful fonts and graphics, including a woman holding her hands in a pistol position with Gelnique (oxybutynin chloride) on her fingertips. But risk information is on the bottom of the ad in “extremely small” text, according to the letter dated Nov. 30 and released late Thursday by the FDA’s advertising division.

In addition, Watson presented the most common adverse events before it presented more serious risks.

The ad also misleadingly presents trial data, the letter says. It contains the claims “smart gel technology is her weapon against wetting” and “significant reduction in incontinence episodes … 71%.” But the bottom corner contains a footnote in small font that says, “Represents median change from baseline. Reduction with placebo was 55.6%.”

The claims also imply that Gelnique is useful in a broader range of conditions or patients (i.e., for all types of incontinence) than has been demonstrated. Gelnique is indicated for overactive bladder with symptoms of urge urinary incontinence, urgency and frequency, the letter notes.

Further, the claim about smart gel technology misleadingly implies that the gel formulation offers an advantage over other overactive bladder treatments.

The ad also omits a precaution about skin hypersensitivity in 0.5 percent of patients.

It claims the drug “fits into a woman’s skin care routine,” but this claim is misleading because the occurrence and management of skin hypersensitivity and application site reactions do not necessarily fit into a woman’s skin care routine, the FDA says.
Watson will look at the points in the letter and will respond appropriately, company spokesman Charlie Mayr told DID Friday.

The letter is available at www.fdanews.com/ext/files/UCM236399.pdf. — April Hollis


FDA Final Guidance Provides Details for Public Speakers at Advisory Meetings

The FDA has issued a final guidance that provides details on its expectations of and logistics required for individuals who wish to speak at the open public hearing section of upcoming FDA drug advisory committee meetings.

The final guidance will affect meetings starting in March. In addition to members of the public, it applies to spokespersons from the regulated industry, consumer advocacy groups and professional organizations, societies or other organizations invited to speak.

It includes instructions on the process for requesting speaking time, how the FDA should respond to requests to speak and the behavior the FDA expects from speakers.

The FDA highlighted six key points the guidance covers:

  • People intending to speak at an upcoming meeting should make an oral or written request that includes the speaker’s personal information, discussion topic and time requested;
  • In response, the FDA can decline a request to comment if the discussion topic is not on par with the committee’s work;
  • At the meeting, speakers should introduce themselves to staff and provide any materials necessary for their speech, which are then identified as part of the meeting’s permanent record and are disseminated to committee members;
  • In order to better understand comments, committee members are urged to ask questions of the speakers;
  • Any financial relationships a speaker may have with the topic should be disclosed; and
  • Speakers should sit in the area the FDA designates.

FDA spokeswoman, Pat El-Hinnawy says the guidance completes a process begun in 2005 and expands on procedures in the Federal Advisory Committee Act.

Advisory committees provide expert advice and recommendations to the FDA on regulated products. Each advisory committee meeting includes time for public comment.

The finalized guidance is available at www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM236144.pdf. — Molly Cohen

Customer Service: Kim Williams
(888) 838-5578 • +1 (703) 538-7600
Editorial: Jonathan Block
(703) 538-7660
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, April Hollis, Virgil Dickson, Wilson Peden, Molly Cohen

President: Cynthia Carter; Editorial Director: Pamela Taulbee; Executive Editor: Jonathan Block

Copyright © 2010 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 $1,995. 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 Alka Desai at (703) 538-7669.