Forest Laboratories Inc. has once again been upbraided by FDA for misleading statements made by its sales representatives. This time the agency objected to a pitch about Forest’s respiratory drug Daliresp (roflumilast).

In an Aug. 1 untitled letter, FDA’s Office of Prescription Drug Promotion said it had received a complaint that during a sales call to a physician’s office two sales reps “stated in word or substance that Daliresp was effective for COPD [chronic obstructive pulmonary disease] exacerbations” without presenting the appropriate patient population as described in the approved indication.

The labeling states that the drug is indicated “in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.” The agency said the reps also did not note that Daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm. These limitations of use are included in the indications and usage and warnings and precautions sections of the product labeling.

The agency learned about the sales rep presentations through its Bad Ad Program, an initiative launched in 2010 to encourage people to report misleading drug advertising and promotion. OPDP received a similar complaint from a physician last year that a Forest sales rep had promoted the fibromyalgia drug Savella (milnacipran) for unapproved uses and minimized its risks Also see "Could Forest's DDMAC Letter For Off-Label Promotion Doom CEO Solomon?" - Pink Sheet, 4 May, 2011..

FDA expressed exasperation that the company has not heeded its previous communications about Daliresp. The sales call at issue took place on Oct. 12, 2011. OPDP noted that prior to that, it sent Forest May 2011 and July 2011 letters with advisory comments about proposed launch materials for Daliresp. FDA approved the drug in May 2011.

“Among other concerns, OPDP recommended that Forest remove claims that implied that Daliresp is useful in a broader range of conditions or patients than has been demonstrated by substantial clinical experience,” FDA stated. “OPDP is concerned that Forest is continuing to promote its prescription products in a violative manner despite clear direction from OPDP.”

Corporate Integrity Agreement Did Not Prevent Misleading Pitch

The agency also suggested that Forest’s conduct was in conflict with its 2010 corporate integrity agreement with HHS’ Office of Inspector General. Forest inked the agreement as part of a settlement with the Department of Justice to resolve a series of charges, including the off-label promotion of its antidepressant Celexa (citalopram) Also see "Forest Admits To Knowingly Obstructing FDA Inspection In Guilty Pleas On Levothroid, Celexa Marketing" - Pink Sheet, 15 September, 2010..

The CIA “requires Forest to ensure that its policies and procedures address ‘appropriate ways to conduct promotional … function in compliance with all applicable FDA requirements’” and to provide specific training to its employees engaged in promotional functions, OPDP stated.

Asked about FDA’s letter, Forest said its policy strictly prohibits the type of statements alleged and that it is looking into the matter.

“We will respond fully to the FDA and will take any appropriate action once our investigation is complete,” the company said in a statement. “If our investigation corroborates the alleged facts of this incident, we will report it under our corporate integrity agreement as required and would remain in compliance with our corporate integrity agreement.”

Dismissing Risks With Anecdotes

In addition to broadening the indication for Daliresp, FDA said the sales reps also minimized serious risks associated with the drug.

“Specifically, while the sales representatives responded to direct questions regarding the risks of weight loss and psychiatric events including suicidality in a manner which is consistent with the warnings and precautions section of the Pl, these risks were immediately downplayed with anecdotal claims regarding other physicians who have prescribed the drug, were pleased with it, and were not reporting any adverse events,” OPDP wrote.

“Furthermore, the sales representatives minimized the risk of weight loss by indicating that this adverse reaction may actually be beneficial in COPD patients who are overweight,” the agency said. However, OPDP noted that this is in direct contrast to the warnings and precautions section of the labeling, which says discontinuation of Daliresp should be considered if unexplained or clinically significant weight loss occurs.

At an analyst meeting in June, Forest noted its plans to build a competitive respiratory franchise and the steps it is taking to differentiate its products. As part of that effort the company is currently conducting a 2,300-pateint post-marketing study to show the benefits of Daliresp when used with the standard-of-care and seeking to educate primary care physicians about treatment options Also see "Forest’s Respiratory Pipeline: Can It Open The Revenue Airway?" - Pink Sheet, 26 June, 2012..

OPDP requested Forest to immediately cease violative promotions activities and to submit a written response to its letter on or before Aug. 16.

Daliresp Sales Pitch Draws FDA Letter After Forest Fails To Heed Advisory Comments

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