Basement Beat: Ask Upton questions about ‘21st Century Cures’
I’m wondering if any of you have any questions for U.S. Rep. Fred Upton.
He announced recently the House Energy and Commerce Committee will spend the next several months gathering input on how to streamline the federal drug approval process. He’s calling the effort “21st Century Cures.”
Upton writes that the committee “will begin a series of listening sessions and roundtables to gather advice and advance ideas about how to streamline the approval process, spur more scientific collaboration and ensure the United States remains the world leader in this field.”
He has likened the current regulatory process as having been designed when the Beatles released their Sgt. Pepper album 50 years ago—while medical science, social networks and computer technology have all undergone a revolution in advancement.
Upton said that “demands that we take a fresh look at our drug approval regime and make sure it is taking advantage of all these new tools.”
Too slow: He said the current U.S. Food and Drug Administration is ill-equipped to address the scientific reality that diseases mutate all the time, requiring multiple therapies.
Social networks: He said the FDA has been reluctant to use social networks to understand the diversity of the illnesses, citing specifically “23andMe”—a company that analyzes DNA for a fee. While consumers may still have the company help them determine their ancestry, the FDA last year ordered them to stop screening for genetic diseases.
(It gets kind of complex here, but, basically, the company is evaluating medical risk for diseases; the FDA is unconvinced as of yet that the company’s service is accurate enough.) So, here, Upton is calling 23andMe an innovator that needs to be helped not hindered, and the FDA is doing what it aims to do—ensuring that things that claim to be medically significant are, in fact, so.
Clinical trials: Upton also believes modern technology can lower the costs of clinical trials.
“Communities of people online, along with companies with molecular and genetic databases, can help target, contact and monitor people much more efficiently than the current clinical trial process. We now also have the ability to better target participation in research and dynamically adapt protocols as we learn.”
Being less risk-averse: Upton also believes the FDA should “modify its risk culture,” believing that there are more tools to keep the public safe even amid “more rapid and innovative treatment experimentation.”
Partnerships: Finally, he wants to encourage better collaboration between government agencies and private companies. As an example, he pointed to National Institutes of Health director Francis Collins announcing the “Accelerating Medicines Partnership” initiative, “a new collaboration between the government and drug companies.
“Our FDA regulatory structure should also encourage greater collaboration among scientists, doctors, patients and big data analysts.”
The reason I ask is because Upton is going to try meeting with me next week to chat about the 21st Century Cures effort. Send in your questions for Fred, and I’ll ask him for you.
Do you think an FDA that takes more risks is a good or bad thing?
My opinion on first blush? As I understand it, the FDA is already vastly undermanned and is doing a bare minimum job of keeping an eye on things. Not the agency I’d have in mind to speed things up for the sake of getting things to market sooner. Studying drugs, in my opinion, should be a deliberative, careful process.
Here’s something else to think about. One of the oft-cited reasons for high drug prices in the United States is that you’re paying for all the regulatory hoops the company has to jump through to ensure they are safe and effective.
What are the odds drug prices will not go down even if clinical trials start costing less. Not good, I’d say.
Also, all of this seems like it will only allow quack medicine even more opportunity to slip through the cracks and rip people off. In addition, it’s bad enough the FDA has had to punt on the mountain of nutritional and dietary supplements and homeopathy products—you’ve seen the blanket label on those bottles: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Awesome. We get that instead of: “The FDA has studied this product’s effectiveness and found it has none. You are paying for expensive urine.”
Anyway, send your questions for Rep. Upton to me, and I’ll put them to him.