Small Companies Turning To CDER Ombudsman For Help With Drug Approvals

While the CDER ombudsman dealt with far fewer complaints overall in 2011 than in 2010 due to administrative changes, smaller companies are increasingly asking for help in certain key areas of drug development.

Amid a massive general decline in the number of initial queries filed with the FDA Center for Drug Evaluation and Research Ombudsman, the number of industry queries is on the rise, driven by small companies’ need for help navigating the drug approval process, according to the ombudsman’s annual report.

Notably, 69% of the 153 initial contacts from industry, consultants, media, whistleblowers, law firms and research sponsors came from commercial sponsors in 2011, up from 53% of the 145 initial queries in 2010. “More of the commercial sponsors were smaller, emerging biotechnology and pharmaceutical companies with less experience interacting with the FDA than larger, more established pharmaceutical companies,” the annual report notes. “The smaller companies often asked the ombudsman for advice and help understanding their options when they hit a ‘snag’ in their drug development plan.”

This could be because smaller firms are less familiar with the drug approval process than bigger firms and also are more likely to submit products “that have no established regulatory path,” the report says. “Though welcome, this can be a challenge both for CDER and companies during development and review.”

More and more of CDER’s overall workload is coming from so-called “emerging sponsors” (Also see "An Emerging Approval Trend At FDA: More First-Time Sponsors" - Pink Sheet, 19 Jan, 2012.). Office of New Drugs Director John Jenkins has discussed how the growing proportion of applications with first-time sponsors has affected the workload for the agency, and new communication mechanisms built into the Prescription Drug User Fee Act V agreement are aimed at improving that process (Also see "Emerging Sponsors And FDA: Will Better Communication Under PDUFA V Ease Inherent Tensions?" - Pink Sheet, 2 Jan, 2012.).

Total Requests Are Down As Consumer Complaints Get Redirected

Overall, however, Ombudsman Virginia Behr reported only 282 initial contacts in 2011, less than one-third the 1,015 initial contacts she received in 2010. The biggest single reason for this dramatic decline was that the 2010 numbers were artificially swollen by an organized campaign to protest the Endocrinologic and Metabolic Drugs Advisory Committee’s Sept. 16, 2010 vote against approving Arena Pharmaceuticals Inc.’s weight loss drug Lorqess (lorcaserin) – which generated 467 complaints to the CDER ombudsman (Also see "Complaints To CDER Down, But Lorcaserin Weighs Heavily At Ombudsman's Office" - Pink Sheet, 11 Apr, 2011.).

Even excluding the Lorqess complaints, however, there were 548 initial contacts with the CDER ombudsman in 2010, so the 2011 figures still represent a decline of nearly 50%. This is in part a result of a change in the way the annual report is compiled. Starting with 2011, Behr did not include in the count contacts she refers on to CDER’s Division of Drug Information.

The 2011 report also says many potential questions may have been answered through the new Rare Diseases Program, the Drug Shortages Program, the revised guidance on user fee waivers, reductions, and refunds (the draft version of which was released in March 2011 and the final version in September), and a new Ombudsman FAQ posted online. Also, the “Bad Ad” Program now absorbs complaints about possibly violative drug ads (Also see ""Bad Ad" Program Set To Expand After Opening Spigot Of Complaints In Year One" - Pink Sheet, 20 Jun, 2011.).

Complaints from industry and FDA employees basically held steady; all of the decline in initial contacts with the ombudsman took place in the category of consumers, advocacy groups, health care professionals, consultants and others, which seems to suggest that the drop off stems from the reclassification that directed the inquiries to other FDA programs.

Excluding the lorcaserin affair, the consumer category accounted for 351 contacts in 2010, 64% of the total. Such requests plummeted nearly six-fold in absolute numbers in 2011 to 63, or 22% of the year’s total. Industry, consultants, media, whistleblowers, law firms and research sponsors submitted 153 contacts in 2011, 55% of the total, compared with 145 in 2010, 26% of the total. FDA employees were responsible for 66 contacts in 2011, 23% of the total, compared with 52 complaints in 2010, 10% of the total.

What People Hate Stays Consistent

Topics of complaint common to both 2010 and 2011 included:

• Drug non-approval or delays in the approval process, including clinical holds placed on clinical trials;
• Enforcement actions, decisions and documentation from FDA’s Office of Regulatory Affairs and Office of Compliance, such as Forms 483, Warning Letters, and import/export detentions;
• Appeals processes, including formal dispute resolution assistance; and
• Problems with the new electronic drug registration process, of which the 2011 report says there were “many fewer than previous years,” but there were 10 complaints.

Complaints about “enforcement action on an unapproved drug” weren’t mentioned in the 2010 report, but the 2011 report says there has been an uptick in these in the past couple of years as a result of the Unapproved Drugs Initiative and FDA denials of Certificates of Pharmaceutical Product that are needed for export. “FDA only issues a CPP if the drug product is legally marketable in the U.S.; some companies expected a CPP to be issued even though their drug is considered an unapproved drug in the U.S.,” the report explains.

There was one complaint in 2011 that was specifically about disagreement on a Special Protocol Assessment, FDA said in an email. “A lot of time was spent on that case.” The agency clarified that in 2010 there was one case where the company hadn't heard about the status of the SPA review. But, it noted, “SPA review is often tied in with other application issues; if it is not the primary complaint, then it is not necessarily recorded as such.”