Mary Parks will take substantial experience with safety issues to her new job as deputy director of the Office of Drug Evaluation II.

Parks moves up from her position as director of the Division of Metabolism and Endocrinology Products, where she has overseen the development and implementation of guidance for assessing cardiovascular risk in diabetes drugs and the agency’s acceptance of obesity products.

ODE II Director Curtis Rosebraugh, who announced the promotion in an internal memo, said there will be a transition period as the agency identifies a new leader for DMEP and Parks completes some pending projects.

He noted that Parks “has been involved in many controversial issues, has guided DMEP with a firm and steady hand and has ably represented the agency with stakeholders.” She first joined FDA as a medical officer in DMEP in 1998.

One of the agency’s controversial decisions involving the division – the refusal to remove GlaxoSmithKline PLC’s diabetes drug Avandia (rosiglitazone) from the market – soon will be revisited. At a June 5-6 joint session, the Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management Advisory Committees will review a re-adjudication of the RECORD study of the drug Also see "Avandia RECORD Study Re-Analysis To Get FDA Committee Scrutiny" - Pink Sheet, 12 April, 2013..

Center for Drug Evaluation and Research Director Janet Woodcock ordered the re-adjudication when she decided to leave the drug on the market with a Risk Evaluation and Mitigation Strategy in the wake of disagreement between the Office of New Drugs and the Office of Surveillance and Epidemiology about the strength of cardiovascular risk data for the drug Also see "Anatomy Of The Avandia Decision: FDA’s Woodcock Splits The Difference Between OND, OSE Views" - Pink Sheet, 4 October, 2010..

The RECORD study found an increased risk of heart failure but was inconclusive with regard to overall cardiovascular morbidity and mortality compared to standard glucose-lowering drugs, while meta-analyses and observational studies indicated a CV risk.

OND officials, including Parks, were reluctant to base a withdrawal decision on those findings, or to recommend that patients first try other therapies. She voiced concern it would set a precedent in which “evidence from meta-analyses and observational data and their non-robust signal of excess risk will be relied upon to recommend use of one drug over another within and across a broad class of drugs.”

Assessing CV Risk In Diabetes, Obesity

As director of DMEP since 2006 and deputy director for four years prior to that, Parks was able to shape the CV guidance for diabetes drugs released in 2008 Also see "FDA’s Diabetes Guidance On CV Risk Will Get First Test With Pending NDAs" - Pink Sheet, 22 December, 2008..

How FDA will implement the guidance remains an evolving process as the agency gains experience with development programs, according to Rosebraugh.

Parks addressed one of the implementation issues during an advisory committee on Janssen R&D LLC’s Invokana (canagliflozin) when she said statistical issues do not preclude using a single trial to rule out an 80% increase in CV risk prior to approval and a 30% risk afterwards Also see "Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel" - Pink Sheet, 21 January, 2013.. FDA approved Invokana March 29 Also see "J&J Gains FDA OK For First-In-Class Type 2 Diabetes Drug Invokana" - Pink Sheet, 29 March, 2013..

The agency also is allowing Orexigen Therapeutics Inc. to submit interim data from a CV outcomes trial for its obesity drug Contrave (naltrexone SR/bupropion SR) when it re-files the NDA for the drug Also see "Orexigen Defines A Way To Get The Contrave PDUFA Clock Ticking" - Pink Sheet, 7 January, 2013.. The resubmission was necessitated by safety concerns raised in the pivotal trials.

FDA has not yet issued CV guidance for obesity drugs, but at a 2012 meeting where the Endocrinologic and Metabolic Drugs Advisory Committee supported a two-step approach to evaluating risk, the agency said drugs with an identified CV signal must be evaluated in a pre-approval outcomes trial Also see "CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement" - Pink Sheet, 30 March, 2012..

Beyond Metabolic And Endocrinological Diseases

As Rosebraugh’s deputy, Parks’ attention will expand beyond DMEP to the Division for Anesthesia, Analgesia and Addiction Products and the Division for Pulmonary, Allergy and Rheumatology Products.

Both divisions soon will go to advisory panels. DPARP will seek input from the Arthritis Advisory Committee July 22 on the impact of classification criteria developed by the SpondyloArthritis international Society (ASAS) for patients with axial spondyloarthritis on review decisions for drugs to treat the disease Also see "Arthritis Patient Classification To Be Key Issue In TNF Inhibitor Reviews" - Pink Sheet, 30 May, 2013..

On July 17, the division will take QRxPharma Ltd.’s NDA for MoxDuo (morphine/oxycodone), the first combination of two drugs in the same class, to the Anesthetic and Analgesic Drug Products Advisory Committee ([A#14130117002]).

Opioids have been a focus of the division in recent years with the development of a Risk Evaluation and Mitigation Strategy for extended-release/long-acting products in July 2012, the release of draft guidance for gaining abuse-deterrent claims in January and the granting of such a claim to Purdue Pharma LP for reformulated OxyContin (oxycodone HCl) in April ([A#14130416009]).

The REMS will remain on the division’s agenda as data comes in to assess the program’s effectiveness Also see "Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment" - Pink Sheet, 16 July, 2012.. Also awaiting decisions are a Drug Enforcement Administration request for up-scheduling of hydrocodone products, an NDA for Zogenix Inc.’s single-entity hydrocodone drug Zohydro ER and a petition to indicate opioids only for severe pain and set a maximum daily dose for patients with non-cancer pain Also see "FDA’s Opioid To-Do List Could Redefine Pain Market For Brands, Generics" - Pink Sheet, 18 February, 2013..

Rosebraugh did not set a specific date for Parks to complete transition to the deputy director position, which currently is vacant. Eric Colman is deputy director of DMEP.

FDA’s Parks Expands REMS Portfolio With Move To ODE II Deputy Slot

More from Drug Safety

More from Pink Sheet