In his article in The Hill, entitled "FDA Should Play Key Role in Lower Drug Costs", former Congressman Ed Towns gets it wrong. He claims drug companies want the FDA to make it harder for doctors to prescribe biosimilars." He wants the FDA to hand over clinical data developed by innovator firms to generic companies well before the full patent life of the product expires.
Actually it's the small biotech startups and medical innovation that would be screwed if Towns has his way
My late colleague John Vernon Jr. explains why cutting IP protections to biologics will hurt Americans (from is article EXPLORATION OF POTENTIAL ECONOMICS OF FOLLOW-ON BIOLOGICS AND IMPLICATIONS FOR DATA EXCLUSIVITY PERIODS FOR BIOLOGICS. )
"A minimum of 17 years of data exclusivity or data protection is required to provide the necessary incentives for continued biotech R&D investments...evidence suggests that these incentives are in fact inadequate for pharmaceuticals in light of the social rate
of return to both pharmaceutical and medical R&D."
Vernon concluded that at present, the U.S. is under-investing in new medicines. "One study suggests that for every $1,345 invested in pharmaceutical R&D, a U.S. life year is gained, on the average. "
This return could be even higher if FDA regulation did not ratchet up the cost and complexity of drug approvals. We can find common ground on this important point!
Actually it's the small biotech startups and medical innovation that would be screwed if Towns has his way
My late colleague John Vernon Jr. explains why cutting IP protections to biologics will hurt Americans (from is article EXPLORATION OF POTENTIAL ECONOMICS OF FOLLOW-ON BIOLOGICS AND IMPLICATIONS FOR DATA EXCLUSIVITY PERIODS FOR BIOLOGICS. )
"A minimum of 17 years of data exclusivity or data protection is required to provide the necessary incentives for continued biotech R&D investments...evidence suggests that these incentives are in fact inadequate for pharmaceuticals in light of the social rate
of return to both pharmaceutical and medical R&D."
Vernon concluded that at present, the U.S. is under-investing in new medicines. "One study suggests that for every $1,345 invested in pharmaceutical R&D, a U.S. life year is gained, on the average. "
This return could be even higher if FDA regulation did not ratchet up the cost and complexity of drug approvals. We can find common ground on this important point!
