FDA reshuffle for better decision-making

by emma 16. September 2011 13:10

Pf industry news

The FDA has changed the way it reviews new cancer drugs in the hope to make faster and better informed decisions.

The Agency’s Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganised and renamed the Office of Hemotology and Oncology Products (OHOP).

Janet Woodcock, CDER Director, said: “Under the new office structure, the Agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market.”

The new department includes four separate drug review units, aimed at increasing the level of expertise. The Division of Oncology Products 1 (DOP1), and Division of Oncology Products 2 (DOP2) units will each focus on a short list of solid tumours. The Division of Hematology Products (DHP) unit will assess haematological tumours, while the new Division of Hematology Oncology Toxicology (DHOT) will handle non-clinical pharmacology and toxicology regarding cancer therapies.

Dr Richard Pazdur, Head of the department, said: “As the practice of oncology and the treatments being developed for these diseases have become more complex, we’ve recognised the need and importance of taking a more disease-specific review approach to these therapies.”

He also added that the reorganisation aligns the FDA with the structure of leading cancer treatment centres, academic programmes and the National Cancer Institute.

The department’s previous system assessed drugs separately from biologics under three divisions: Division of Hematology Products (DHP), Division of Drug Oncology Products (DDOP) and Division of Biologic Oncology Products (DBOP).

Criticism of NHS reform continues

by emma 6. September 2011 14:52

Pf NHS News

The Health Bill in its current form will lead to the “end of the NHS”, a union chief has claimed.

Christina McAnea, Head of Health at Unison, said that the Bill will make matters worse for the NHS, tempting cash strapped hospitals to prioritise paying patients, “pushing NHS patients even further down the ever-spiralling waiting lists.”

But Health Secretary Andrew Lansley dismissed these allegations that the Bill would lead to the privatisation of the NHS, as ‘scaremongering’.

Unison’s comments come at the beginning of the week when Parliament will renew the debate around Lansley’s controversial plans for the health service.

The concerns focus on the continued competitive role of the private sector, increased bureaucracy and plans for change involving failing areas of the NHS.

Ms McAnea said: “It should be obvious to the Government that now is not the time to bring in this massive, damaging NHS reorganisation.”

Mike Farrar, Chief Executive of the NHS Confederation, said: “There is a real danger that the NHS could find itself in paralysis”.

But Lansley said the policies would improve the health service and improve outcomes for patients. “The reality is that we’re giving more power and choice to patients over how they get treated, keeping waiting times low and cutting bureaucracy so more cash gets to the front line,” he said.

MPs will debate the Health Bill over the next two days, following a series of concessions made by ministers in June. The strong opposition to the reforms offers a major challenge and delay for the Government.

Shadow Health Secretary John Healey has complained that the Government appeared to be rushing the “bad bill” through the House of Commons. He said there were over 1,000 amendments that needed debating.

Baroness Thornton of the Labour Party says the House of Lords is prepared to form a special committee if necessary, to scrutinise the bill in “great detail” later in the autumn, which could delay the process even further.

FDA reshuffle to ‘ease agency-industry relations’

by emma 24. August 2011 15:00

Pf industry news

The FDA has appointed Dr Stephen Spielberg to the new post of Deputy Commissioner for Medical Products and Tobacco.

The appointment comes as part of a reorganisation of the Agency’s management structure, in a bid to ease agency-industry relations following Joshua Sharfstein’s exit of the FDA in January.

Peter Pitts, former FDA associate commissioner for external relations, commented that the reshuffle will bring “a stronger voice in agency policy development”.

Dr Spielberg’s post will oversee the centres for drugs, biologics, medical devices and tobacco products, as well as heading special medical programmes.

He currently works as Director of the Centre for Personalised Medicine and Therapeutic Innovation at Children’s Mercy Hospital in Kansas City and has previously worked at Merck and Johnson & Johnson.

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