FDA's risk assessment working group is considering developing specific recommendations on which lab test results could signal safety problems for drugs under review.

For "supplementary data, and in that regard we're talking about vital signs, ECG's and laboratory data,...I think this is one thing to be flushed out some as we go on in our efforts to discuss the guidances," CDER Neuropharmacological Drug Products Division Safety Group Team Leader Judy Racoosin, MD, said at the Regulatory Affairs Professionals Society's annual conference Oct. 7.

"We have some ideas about...what kind of analysis we would want to see. Do we want to see a percentage of patients who have a certain elevation of transaminase?" Raccosin said.

"It's certainly possible that we may come out with some specific recommendations about that sort of thing."

The Prescription Drug User Fee Act reauthorization directs the agency to publish final guidances on risk assessment, risk management, and pharmacovigilance by the end of fiscal 2004 (¹ Also see "FDA Plans Three Risk Management-Related Guidances Under PDUFA III" - Pink Sheet, 1 July, 2002., p. 20).

To oversee development of the guidances, FDA has established working groups for each of the three areas to be covered by the guidances. Racoosin is chairing the risk assessment working group (² Also see "Rx Risk Management Guidances: FDA To Seek Input Through Public Meetings" - Pink Sheet, 30 September, 2002., p. 11).

FDA expects to provide more specific advice to industry on how to assess drugs that prolong the QT interval. A working group chaired by Cardio-Renal Drug Products Division Director Douglas Throckmorton, MD, is developing a guidance (³ Also see "FDA Working On QT Interval Guidance Under Cardio-Renal’s Throckmorton" - Pink Sheet, 15 April, 2002., p. 18).

"One thing that is already in the system that we anticipate will be continued and likely strengthened is the pre-approval safety conference that occurs between the new drug reviewing division and the Office of Drug Safety," Racoosin said.

"That's really the opportunity to share what we've learned and pass on to our colleagues at the ODS who will be monitoring the safety of the drug approval, so they already know how [the Office of New Drugs] feels about certain safety issues."

The meetings are also used "to talk about whether any formal studies, Phase IV type studies, would be needed," she said.

CDER Surveillance, Research & Communications Division Support Director Anne Trontell, MD, who is chairing the risk management working group, noted that her group aims to increase and improve the risk management options available to the agency.

Trontell listed four questions facing the working group: "How can we increase the range of options between communication of risk and product withdrawal? How can we promote standardization of tools and consistent application of tools? How can we foster evaluation of program effectiveness? How can we address unintended consequences?"

Trontell's questions echo concerns cited in the Office of Drug Safety's PDUFA III proposal, which called for funding for the risk management "toolkit" collaboration between FDA and the Pharmaceutical Research & Manufacturers of America (⁴ Also see "FDA User Fee Proposal Calls For Funding Of Risk Management “Toolkit”" - Pink Sheet, 21 January, 2002., p. 21).

The PhRMA/FDA toolkit group, which began meeting in fall of 2001, focuses on developing a systematic approach to risk management programs (⁵ Also see "Pfizer “Toolkit” Proposal Focuses On Adverse Event Signals" - Pink Sheet, 17 December, 2001., p. 28).

CDER Drug Risk Evaluation Division Director Julie Beitz, MD, who chairs the pharmacovigilance working group, told RAPS that her group would be focusing its efforts on developing more rigorous identification of postmarketing safety data collection needs, as well as more formalized development and conduct of pharmacovigilance plans.

PDUFA III allows user fees to fund FDA's post-marketing surveillance activities in the first two or three years after launch (⁶ Also see "FDA Can Fund Use Of Rx Utilization Databases Under PDUFA III" - Pink Sheet, 18 March, 2002., p. 6).

The three working groups held their initial meetings on Oct. 3 and 4. Draft guidances are expected to be published in September 2003; final guidances are planned for September 2004.

FDA Rx Risk Assessment Guidance May Detail Lab Test Parameters

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