In an effort to find a counterpoint to industry concerns about follow on biologic legislation (here's goes my chance to land on his speed dial) Robert Pear mis-characterizes Janet Woodcock's clear and unambiguous testimony stating that the FDA had the regulatory authority and know how to develop a pathway for the approval of FOBs. He makes it seem that Woodcock claims you don't need human testing to establish that two biologics are interchangeable.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''
Woodcock said nothing of the sort. Here is what she said:
"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."
Here is a link to Dr. Woodcock's testimony.
http://www.fda.gov/ola/2007/protein32607.html
Pear thinks it gave legislation for FOBs an "unexpected boost."
Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings.
Brand-name drug manufacturers have urged Congress to require human trials before allowing the sale of any products billed as comparable or equivalent to biotechnology medicines already on the market.
''Some level of clinical testing should be required in all cases,'' said Dr. Susan D. Desmond-Hellmann, president for product development at Genentech.
Dr. Jay P. Siegel, a senior scientist at Johnson & Johnson, said: ''I would never take a biologic that had not been tested in humans. The risks are too high.''
But Dr. Woodcock said: ''Where trials are not needed, it is of questionable ethics to repeat them. The use of human subjects for trials that are not needed is not desirable.''
Woodcock said nothing of the sort. Here is what she said:
"To establish that two protein products would be substitutable, the sponsor of a follow-on product would need to demonstrate through additional clinical data that repeated switches from the follow-on product to the referenced product (and vice versa) would have no negative effect on the safety and/or effectiveness of the products as a result of immunogenicity. For many follow-on protein products -- and in particular, the more complex proteins – there is a significant potential for repeated switches between products to have a negative impact on the safety and/or effectiveness. Therefore, the ability to make determinations of substitutability for follow-on protein products may be limited."
Here is a link to Dr. Woodcock's testimony.
http://www.fda.gov/ola/2007/protein32607.html
Pear thinks it gave legislation for FOBs an "unexpected boost."
Really? The holy grail for the generic industry and Bashir Assad's new accountabilabuddy Henry Waxman is substitution. That sound you hear is the air being let out of the FOB money saving balloon just like when Waxman and Ron Pollack (proud recipient of money from George "de-Nazify America/majority Halliburton shareholder" Soros pushed Medicare price control legislation claiming $200 billion in savings.
