Drug Industry Daily - April 8, 2010 Issue

Vol. 9 No. 68

FDA to Reevaluate Performance Measures, Post Results Online

Drugmakers will soon be able to access online more information on the timing and results of FDA inspections and the number of ANDAs waiting to be reviewed under a new transparency program launched by the agency.

The program, known as FDA-TRACK (Transparency Results Accountability Credibility Knowledge), was launched by the agency Wednesday and is designed to serve as a new system for measuring performance at FDA, Joshua Sharfstein, FDA principal deputy commissioner, said.

Each of the FDA’s centers and more than 100 program offices will have their own performance measures, and the statistics on whether they have been met will be reported and posted monthly in an online dashboard.

Additional areas to be measured will include the timeliness of reviews, the number of high-risk inspections completed and the completion of key research projects, the FDA says.

The measures are a change from how the agency has previously evaluated its performance, which focused too much on broad, overall measurements such as the number of total inspections completed, Sharfstein said.

FDA-TRACK will post measures in four categories: common measures, key center director measures, program measures and key projects. “Our measures are monthly, there are more of them and they are targeted to things that really matter,” Sharfstein said.

The first dashboards will be released this month, according to the agency.

Prior to publishing the dashboards, program offices will present their performance measures and results to FDA senior leadership at the same time each quarter. CDER is scheduled to present its data on the fourth Monday of the first month of each quarter; CBER’s briefing is on the first Wednesday of the second month of each quarter, according to the FDA.

After the briefings, the data will be made public at www.fda.gov/fdatrack. The agency is encouraging the public to comment on the overall program and the data presented on the site. “We’re going to be open to questions about our performance, but we’re ready to do that,” Sharfstein said.

Indeed, the FDA’s performance measures have come into question recently, in particular in a Government Accountability Office report released last month that encouraged the agency to realign its internal performance measures to focus more on public health goals (DID, March 25).

The new program will do that, the FDA says, by requiring senior managers to develop, track and report performance measures that will improve the agency’s accountability to the public.

The agency also has been working to increase the public’s knowledge about how it operates through the Transparency Initiative, the first phase of which was initiated earlier this year (DID, Jan. 13).

That program included the launch of an online resource — known as FDA Basics — designed to help consumers better understand what the agency does. It posts questions and answers about the agency and the products it regulates, short videos explaining agency activities and interviews with agency personnel about the work of their office.

The FDA is asking for input from the public on FDA-TRACK. — David Belian


Forest’s Daxas Fails to Win Recommendation From FDA Panel

Forest Research Institute’s investigational chronic obstructive pulmonary disease (COPD) drug failed to muster the votes Wednesday for a recommendation from an FDA panel.

The Pulmonary-Allergy Drugs Advisory Committee voted 10–5 against Daxas (roflumilast) as a COPD maintenance treatment. The panelists also suggested Forest conduct clinical trials comparing Daxas to existing COPD treatments, such as inhaled corticosteroids, to obtain more data.

One possible side effect associated with the drug involved a higher incidence of psychiatric adverse events in a group of 5,766 patients taking 500 mcg of the drug daily than the control group — including three suicides and two suicide attempts, according to an FDA staff briefing.

Marco Taglietti, Forest’s chief medical officer, said the event rate was too low to draw a conclusion about association with the drug. Other safety signals included gastrointestinal adverse reactions, weight loss and a higher incidence of common cancer types seen in clinical trials.

However, a statistically significant but modest reduction in airway obstruction was seen in patients treated with roflumilast in the one-year pivotal and supportive studies, compared with placebo, Anthony Durmowicz, clinical team leader of CDER’s Division of Pulmonary, Allergy and Rheumatology Products, told the panel.

The committee first voted 9–6 that Daxas had demonstrated adequate efficacy and 9–6 that it showed sufficient safety, before deciding against a recommendation for FDA approval.

Roflumilast, a new molecular entity, is a selective phosphodiesterase type 4 inhibitor designed to act as an anti-inflammatory agent. Larry Olanoff, Forest’s chief operating officer, said after the meeting that the company will work to address the FDA’s concerns.

The FDA also discussed Forest’s attempt earlier this year to narrow the drug’s proposed indication during the review cycle. Forest submitted revised product labeling — that narrowed the indication to reduction of exacerbations of COPD — in January after acquiring the NDA from Nycomed late last year (DID, April 6).

“The change of indication six months into the review is somewhat problematic,” Durmowicz said. “By that time, review period is half over” and a change would affect the efficacy analysis, he added. Durmowicz pointed out that although indication changes are sometimes made during the review cycle, the FDA typically initiates those changes. — April Hollis


Federal Appeals Court Tosses Seroquel Diabetes Claim

A federal appeals court upheld the dismissal of a lawsuit brought by a woman who claimed AstraZeneca’s antipsychotic Seroquel led to her diabetes.

The U.S. Circuit Court for the 11th Circuit ruled Tuesday that the U.S. District Court for the Middle District of Florida was correct in dismissing the case brought by Linda Guinn.

The District Court granted AstraZeneca a summary judgment last year because Guinn failed to prove Seroquel (quetiapine fumarate) caused her diabetes, according to court documents. Guinn’s suit was one of the first two individual product liability cases involving Seroquel to be dismissed (DID, Jan. 29, 2009).

“The appeals court decision echoes earlier federal and state court opinions that found Seroquel could not be proven to be responsible for plaintiffs’ alleged injuries,” AstraZeneca spokesman Tony Jewell said Wednesday. The company is facing thousands of similar cases that are part of a multidistrict litigation related to risks associated with Seroquel, which is approved to treat bipolar disorder and schizophrenia.

In the first Seroquel product liability case to go to trial, a New Jersey jury last month ruled in favor of AstraZeneca.

Last November, AstraZeneca agreed to pay $520 million in a settlement with the U.S. Attorney’s Office in Philadelphia to end an investigation related to the sales and marketing practices for Seroquel (DID, Nov. 2, 2009).

Last year, revenues from Seroquel were $4.9 million, making the antipsychotic one of AstraZeneca’s best-selling drugs.

Linda Guinn v. AstraZeneca Pharmaceuticals LP, et al. was initially filed in the U.S. District Court for the District of Massachusetts before being rolled into the multidistrict litigation and transferred to the Florida court for pretrial proceedings. — Jonathan Block


FDA: Claims for Fat-Dissolving Drugs Are Unproven

The FDA sent warning letters to six medical spas and a Brazilian web marketer this week, citing their false online claims about drugs they say can permanently melt away fat.

The companies made false or misleading statements on their websites about lipodissolve, a procedure in which patients receive a series of injections, according to the April 5 and April 6 letters posted to the FDA website Wednesday.

The drugs most often used in lipodissolve are phosphatidylcholine and deoxychlolate, usually in some combination, the FDA says.

The compounds used by the companies are components of FDA-approved drugs but not actual approved drugs, Kathleen Anderson, deputy director for new drugs and labeling compliance at CDER, said in a press briefing Wednesday.

Adverse events associated with the drugs include permanent scarring, skin deformation and deep, painful knots beneath the skin in the injection area, the FDA says.

Each company has been cited for previous regulatory violations, including unproven claims that the products can be used to treat certain medical conditions, according to the agency. The FDA has issued an import alert against the Brazilian web marketing company. — Meg Bryant


Gilead Sciences Gets Untitled Letter Over Truvada Print Ad

The FDA has sent Gilead Sciences an untitled letter over a direct-to-consumer print advertisement for its HIV treatment Truvada, saying the ad overstates the efficacy of the drug, makes unsubstantiated claims and minimizes its risks.

The ad misleadingly suggests that patients taking Truvada (emtricitabine/tenofovir disoproxil fumarate) as part of an HIV combination therapy will be able to maintain undetectable levels of HIV-1 RNA and increased CD4 cell counts long-term, the letter posted Wednesday says.

The company also minimizes the drug’s risks, which are serious and potentially life-threatening, by presenting claims about the efficacy and benefits of Truvada with colorful text and illustrations, while relegating risk information to several long, single-spaced paragraphs in small type, the FDA says.

The agency asks Gilead to immediately cease the dissemination of the ad and asks the company to respond by April 9 to the letter.

Gilead did not respond by press time to a request for comment on the letter.

The untitled letter can be found at www.fdanews.com/ext/files/UCM207683.pdf. — David Belian

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