Imagine the FDA as an independent federal agency with a specific mission to promote innovation. The Biotechnology Industry organisation (BIO) is calling this the “21st century FDA” and is proposing legislation to Congress to reform the FDA in this way, as well as its drug approval process.
“Currently, the FDA has neither the resources nor the authority to do its job,” chief executive of BIO Jim Greenwood told delegates. “The regulatory process has become too unpredictable, time-consuming and expensive, regulatory science has not kept up with the frontiers of innovation and the agency has been given too many conflicting missions without sufficient resources to perform them.”
The reforms aim to provide earlier access of new treatments to patients and to properly incentivise innovation. Under the proposals, the FDA would become an independent agency (no longer an arm of the Department of Health and Human Services) with an FDA Commissioner with a fixed 6-year term that is not tied to presidential administrations.
Instead of the currently required two “adequate and well controlled” clinical trials, BIO also proposes adopting a “weight of evidence” approach. According to chief executive of Human Genome Sciences Thomas Watkins, the FDA takes 37 months on average to approve a drug.
In talking with Congressmen, BIO recognises the growing debts of Medicare and hopes to address the problem.
“Instead of Congress fixating on the cost of innovative medicines, they should consider this – a new drug that could delay the onset of Alzheimer’s by even five years would save Medicare $50 billion a year,” he said, adding: “that’s what biotechnology can do.“
These past few days have seen several FDA nods for new drug applications. We list the drugs and their companies below.
Do you think these drugs would have benefited from a newly reformed FDA? And if these reforms went through, how would it affect these companies?
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The drug has been available in Europe since 2008, but the FDA declined approval in 2009 due to lack of information. The drug is expected to be part of a new multibillion-dollar market for anticoagulants. Xarelto is said to be the first “oral anticoagulant approved to prevent VTE (a type of blood clot) in joint-replacement surgeries in the US.” Older drugs for this treatment were injectables.
2. Novartis (NVS): Arcapta Neohaler to treat COPD.
The inhaler is approved to treat chronic obstructive pulmonary disease, or “smoker’s cough.” Novartis was hoping for approval of the 150-mcg dose, but only received approval for 75 mcg. The 150-mcg dose is currently sold in Europe and had revenue of $33 million in 2010.
(List compiled by Alexander Crawford)