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encourages innovation while maintaining a commitment to safety and effectiveness upon which Americans rely and that other countries follow,” Shuren said on Feb. 8 in remarks which are posted on the FDA website. “We must turn what has long been considered the Valley of Death into the Pathway to Success.”
Earlier this month, Versant Ventures’ Beckie Robertson, a veteran medical device investor, told a group of med device entrepreneurs in Bothell, WA, that she’s hopeful change will come to the agency. The FDA, she said, “is a political body, and as political winds shift, so will the FDA.”
There’s certainly a lot of angst on Capitol Hill about the unemployment rate remaining stubbornly high at 8.8 percent nationwide, and nobody in either party wants to be seen as making the problem worse. Jobs, Robertson told med device entrepreneurs, “can and may have some influence” in changing the way FDA regulates the device industry.
Makower, who testified before the House Energy and Commerce Health Subcommittee on Feb. 17, isn’t quite as confident that the latest bout of activism is destined to succeed. Yesterday, he told me, “at this point from my perspective nothing has yet improved at FDA, so there is no evidence available yet to be optimistic. The mindset and approach through the ranks continues be focused more heavily on risk aversion rather than risk/benefit balance.” He adds: “Since nothing legislatively has changed to get us here, nothing other than leadership, management and vision is required to fix this situation.”
This issue isn’t making headline news just yet, but if it advances further it will generate attention, and it will attract extremists from both sides. Some on the left will accuse the FDA of being industry’s lapdog, and putting public safety in jeopardy, if it moves an inch toward streamlined processes that allow more innovative products on the market. On the right, there are those (like Newt Gingrich in 1995) who would like to abolish or gut the FDA, as if doctors, patients, and insurers in the free market can sort out what’s safe and effective.
Both of those extreme views strike me as wrong and dangerous. I know it’s been said a million times already, and it sounds Pollyannish, but it’s a shame that we live in such a hyper-polarized world that adults can’t debate drug regulation rationally in public. It’s an important issue that deserves more light than heat. Patients have a lot on the line. If we hashed out these issues more in the open, we could hold important agencies like the FDA more accountable, and avoid the extreme rebalancing act the FDA goes through at least once every generation.
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