Una iniciativa loable de Barack Obama

En el New England Journal of Medicine de hoy se publica un comentario sobre la iniciativa de transparencia de la FDA, originada en una orden directa de Barack Obama.La FDA ha perdido una enorme parte de su antiguo prestigio en estos últimos años, debido a la poca fiabilidad de sus conductas, con perjuicio para la salud de muchas personas, y en buena parte vinculado esto a su asociación con la industria farmacéutica a través de los PDUFA.

En el trabajo “Transparency at the Food and Drug Administration”, sus autores Afia K. Asamoah, J.D., and Joshua M. Sharfstein, M.D. comentan algunas de las propuestas que están en estudio, entre otras:

Elaborate on the FDA’s decisions
At the time the FDA issues a refuse-to-file or complete response letter in response to an original new-drug application, biologics-licensing application, or efficacy supplement for such applications, the agency should disclose that it has done so and should simultaneously disclose the refuse-to-file or complete response letter, which contains the reasons for issuing the letter.
Provide increased access to important data
The agency should disclose relevant summary safety and effectiveness information from an investigational application or a pending marketing application, if the agency concludes that disclosure is in the interest of the public health, including when it believes that doing so is necessary to correct misleading information about the product that is the subject of the application.
Illuminate enforcement efforts
The agency should disclose the name and address of the entity inspected, the date or dates of inspection, the type or types of FDA-regulated product involved, and the final inspectional classification — official action indicated, voluntary action indicated, or no action indicated — for inspections conducted of clinical trial investigators, institutional review boards, and facilities that manufacture, process, pack, or hold an FDA-regulated product that is currently marketed. The disclosure of this information should be timed so as not to interfere with
planned enforcement actions.
Support innovation
When an application for a designated orphan human drug or a designated minor-use or minor-species animal drug has been withdrawn, terminated, or abandoned, the agency should disclose, if it so determines through its review, that the application was not withdrawn, terminated, or abandoned for safety reasons and that the product, if ap-
proved, could represent a significant therapeutic advance for a rare disease or for a minor animal species. A disclaimer should accompany the disclosure of this information, indicating that the agency’s expressed views about the product do not reflect whether a subsequent application involving the product will be accepted for filing or will be approved by the FDA.

Finalmente consideran que:

If  the  proposals  were  to  be adopted  and  implemented,  the FDA  would  make  substantially more information about the regulatory  process  available  to  the public.  The  agency  would  disclose, among other things, when a drug or device is being studied
and  for  what  indication,  when an application for a new drug or device  has  been  submitted  or withdrawn by the sponsor, whether there was a significant safety concern associated with the drug or device that caused the sponsor to withdraw an application,
and why the agency did not approve an application. If a report that  is  published  by  a  sponsor were  to  contain  an  incomplete picture about the safety or efficacy of a product, the FDA would be able to provide its analysis to contribute  to  the  scientific  discussion.

Si todo esto se pone en práctica, será una importante fuente de información y claridad para todo el proceso de regulación de medicamentos y aparatos.

Sería interesante, muy interesante, que otras agencias similares, como en el caso de Argentina la ANMAT, cuya información sobre el tema es opaca, hicieran un esfuerzo parecido al de la FDA.

Ver en http://healthcarereform.nejm.org/?p=3440&query=OF

Una respuesta to “Una iniciativa loable de Barack Obama”

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