The New FDA Strategy - The Speech of the New FDA Acting Commissioner

GMP News No. 445

3 August 2004

The NewFDA Strategy -
The Speech of the New FDA Acting Commissioner

On 7 July, the Acting Commissioner of the FDA, Dr Lester M. Crawford,presented the cornerstones of the FDA's future targets to a selectedaudience.

In the following we have compiled someextracts from this presentation.

One of FDA's main targets is the reduction and prevention of healthrisks. Owing to the complexity of FDA's supervisory activities,according to Crawford, this task can only be fulfilled with the help of aneffective risk management. He even sees this approach to be a sine qua nonfor the FDA.

Another focus of the FDA is to protect and improve the health of UScitizens. For this reason, the FDA intends to facilitate efficiency inthe development and manufacture of medicinal products. In this same light,Crawford also sees the modernisation of the FDA. Especially FDA's 'drugreview,' the 'compliance' and the inspections should be based on'state-of-the-art pharmaceutical science.' This is meant to lead to ahigher quality and, at the same time, reduced costs. According toCrawford, one means to get on this way is an exchange of ideas alsooutside the Agency. Above all the International Conference onHarmonisation (ICH) was mentioned expressly by him.

Another possibility is the modernisation of the FDA inspectionprogramme. Comparable to the Team Biologics, which made considerablecontributions to improving the quality and safety of biological productson the one hand and the coordination between the 'centers' and the 'field' onthe other hand, a Pharmaceutical Inspectorate is planned to be founded.This Pharmaceutical Inspectorate will consist of specialists from CDER andfrom the Office of RegulatoryAffairs (ORA). These experts will undergo a specific training enablingthem to assess and supervise in particular highly risky and complexpharmaceutical activities - also within the framework of pre-approvalinspections.

Further cornerstones of the FDA programme are:

  • Improved readability of package leaflets
  • Increased transparency and predictability in the development of newproducts
  • Further containment of illegal imports
  • Restrictions on the patent protection for biogenerics
  • Improved handling of combination products

By 'combination products,' FDA understands therapeutics that combinemedicinal products, biologics and/or medical devices. In order to renderthe regulatory requirements on these products more transparent, the Office of CombinationProducts (OCP) was founded one and ahalf years ago. 

You can read the unabridged text of Dr Crawford's presentation if youclick here

PS. Another item that has been revised is FDA's Guidance Document Agenda. Itcontains a list of documents that are meant to be published for the firsttime or updated. It is e.g. interesting that the FDA is planning topublish a guideline on reprocessing and reworking of biologic APIs andmedicinal products. Thislink will lead you to the document.

Sven Pommeranz

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