Another fine piece of straight-shooting journalism from the FT. The article, “Medical Marvals” (by Andrew Jack and Clive Cookson) looks at the challenges and opportunities of the FDA under Commissioner Peggy Hamburg.
It begins with a symbol:
“Margaret Hamburg had scarcely begun her work as commissioner of the US Food and Drug -Administration over the summer when she travelled to meet her counterparts at the European Medicines Agency in London. The trip symbolised a strengthening appetite for international cooperation between the FDA and the EMEA, at a time when the globalisation of medical products has highlighted continuing regulatory differences and made the demands for co-operation greater than ever before. It also reflected a fresh sense of self-confidence and willingness to communicate externally at the US agency, after several years of unstable leadership and internal demoralisation in the face of criticism from politicians, lawyers, companies and medical researchers alike.”
And ends with a reality check:
“Pitts argues the agency still faces enormous challenges in updating its computer systems and adapting to an era of biological medicines. As for international convergence, he adds it too has limits. Different nations need different bodies to be held accountable, he says.”
And, in between, much useful information and conversation.
The complete article can be found here:
http://www.ft.com/cms/s/0/b8e56a28-e32e-11de-b965-00144feab49a.html
And speaking of the FDA and Peggy Hamburg, the Hill reports that the FDA said "a proposal to enable the importation of cheaper prescription drugs could endanger the US medicine supply and would be difficult to implement." According to The Hill, "These criticisms from Margaret Hamburg, President Barack Obama's FDA commissioner, could prove damaging to an effort by a broad coalition to enact the longstanding goal of easing consumers' access to prescription drugs from countries such as Canada, where the prices are generally lower than in the United States." Sen. Byron Dorgan (D-ND) "introduced his amendment to the healthcare bill on Tuesday with the support of 19 other senators, including four Republicans, setting up a vote Wednesday."
And the Associated Press adds that Senator Dorgan replied to the FDA concerns, saying, "I'm going to go home kind of upset about this letter today from the FDA, which is in my judgment completely bogus." In its letter, the FDA "said that while Dorgan's plan seeks to address safety risks, concerns remain about copycat versions of high-technology biological drugs and about confusion surrounding the distribution of foreign products."
Senator, don’t go home mad. Just go home.
It begins with a symbol:
“Margaret Hamburg had scarcely begun her work as commissioner of the US Food and Drug -Administration over the summer when she travelled to meet her counterparts at the European Medicines Agency in London. The trip symbolised a strengthening appetite for international cooperation between the FDA and the EMEA, at a time when the globalisation of medical products has highlighted continuing regulatory differences and made the demands for co-operation greater than ever before. It also reflected a fresh sense of self-confidence and willingness to communicate externally at the US agency, after several years of unstable leadership and internal demoralisation in the face of criticism from politicians, lawyers, companies and medical researchers alike.”
And ends with a reality check:
“Pitts argues the agency still faces enormous challenges in updating its computer systems and adapting to an era of biological medicines. As for international convergence, he adds it too has limits. Different nations need different bodies to be held accountable, he says.”
And, in between, much useful information and conversation.
The complete article can be found here:
http://www.ft.com/cms/s/0/b8e56a28-e32e-11de-b965-00144feab49a.html
And speaking of the FDA and Peggy Hamburg, the Hill reports that the FDA said "a proposal to enable the importation of cheaper prescription drugs could endanger the US medicine supply and would be difficult to implement." According to The Hill, "These criticisms from Margaret Hamburg, President Barack Obama's FDA commissioner, could prove damaging to an effort by a broad coalition to enact the longstanding goal of easing consumers' access to prescription drugs from countries such as Canada, where the prices are generally lower than in the United States." Sen. Byron Dorgan (D-ND) "introduced his amendment to the healthcare bill on Tuesday with the support of 19 other senators, including four Republicans, setting up a vote Wednesday."
And the Associated Press adds that Senator Dorgan replied to the FDA concerns, saying, "I'm going to go home kind of upset about this letter today from the FDA, which is in my judgment completely bogus." In its letter, the FDA "said that while Dorgan's plan seeks to address safety risks, concerns remain about copycat versions of high-technology biological drugs and about confusion surrounding the distribution of foreign products."
Senator, don’t go home mad. Just go home.
