Results for “fda”

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I know, I know, you are tired of me beating on the FDA. Too bad. The beatings will continue until mortality improves.

Today’s beating, however, concerns hearing aids rather than than vaccines. The current system, much like the optometry racket, requires that hearing aids be purchased through an audiologist:

WEBMD: A pair of hearing aids runs $5,600 on average — a cost that health insurance doesn’t typically pick up. In order to get the devices, people with hearing loss must have a medical exam to rule out the slim chance of a serious medical problem that is causing the hearing loss, or they must sign a waiver opting out of the exam. You can only buy hearing aids through an audiologist or a licensed hearing aid dispenser, who is authorized to test hearing and sell hearing aids.

…choosing a hearing professional limits a person’s hearing aid choices, and changing audiologists as a result of location or personal preference could require a person to change hearing aids, too.

Due in part to these hurdles, once a person starts to lose their hearing, they wait an average of 7 years before they seek help.

The NYTimes continues the story:

By now, we were supposed to be swiftly approaching the day when we could walk into a CVS or Walgreens, a Best Buy or Walmart, and walk out with a pair of quality, affordable hearing aids approved by the Food and Drug Administration….in 2017, Congress passed legislation allowing the devices to be sold directly to consumers, without a prescription from an audiologist. The next step was for the F.D.A. to issue draft regulations to establish safety and effectiveness benchmarks for these over-the-counter devices.

Of course, the FDA is likely to miss the deadline. But even I am willing to cut them some slack, given other more pressing concerns. The real issue, however, is one that the NYTimes doesn’t confront and that is why does the FDA regulate hearing aids at all?

Headphones and earbuds are not regulated as medical devices and hearing aid technology is similar to hearings buds with a sophisticated equalizer. Indeed, you can even buy “personal sound amplification products” that are not FDA regulated or approved. It’s only the somewhat arbitrary declaration that these products are “medical devices” that brought them under FDA regulation to the detriment of consumers. The National Academy of Sciences report agrees writing:

FDA has established regulations for hearing aids, including quality system regulation requirements, mandatory labeling, and pre-purchase medical evaluation (or a documented waiver). These regulations, along with a number of state regulations, have largely restricted the availability of hearing aids to being mainly dispensed through medical, audiology, or hearing instrument specialist venues.

…In examining the Food and Drug Administration’s (FDA’s) requirements for physician evaluation prior to obtaining hearing aids, the committee finds no evidence that the required medical evaluation or waiver of that evaluation provides any clinically meaningful benefit.

Addendum: In some positive news the FDA lifted its ban on the first non-prescription, at-home SARS-COV test and also on a prescription, paper-strip test. Now all we need is a non-prescription paper-strip test! Come on guys.

Since back in April, Michael Kremer, myself, and the AHT team have been advising governments to go big on investing in vaccines. The US, to its credit, made early purchases but they made two mistakes. First, they didn’t buy enough as the Washington Post indicates:

Last summer, Pfizer officials had urged Operation Warp Speed to purchase 200 million doses, or enough of the two-shot regimen for 100 million people, according to people knowledgeable about the issue who spoke on the condition of anonymity because they weren’t authorized to discuss the situation. But the Warp Speed officials declined, opting instead for 100 million doses, they said.

“Anyone who wanted to sell us … without an [FDA] approval, hundreds of millions of doses back in July and August, was just not going to get the government’s money,” said a senior administration official.

But last weekend, with an FDA clearance expected any day, federal officials reached back out to the company asking to buy another 100 million doses. By then, Pfizer said it had committed the supply elsewhere and suggested elevating the conversation to “a high level discussion,” said a person familiar with the talks who spoke on the condition of anonymity because they were not authorized to share the conversation.

In our discussions, we were talking about at least a $70 billion dollar program and optimally double that and we continually faced the sticker shock problem. Investing in unapproved vaccines seemed risky to many people despite the fact that the government was spending trillions on relief and our model showed that spending on vaccines easily paid for itself (the mother of multipliers!). I argued that this was the world’s easiest cost benefit calculation since Trillions>>Billions. But it was hard to motivate more spending—not just in the United States but anywhere in the world. For reasons I still don’t understand anything out of the ordinary–big spending on at-risk vaccines, spending on testing and tracing, challenge trials–was met with a kind of apathy and defeatism. As I said in July:

Multiple people [in Congress] have told me that things move slowly, no one is stepping up to the plate, leadership is absent. “Who is John Galt?,” they sigh. Ok, they don’t literally say that, but that sigh of resignation is what it feels like in the United States today at the highest levels of government.

OWS was actually the one area where there was some action. But there was a second mistake. We argued that governments shouldn’t buy doses but capacity, i.e. they should cover the cost of building a factory or production line in return for an option on doses from that line. The problem with buying doses is that if you buy without a timeline then the company takes all orders and pushes the low-priced orders to the back of the queue. If you demand a timeline, however, that puts a lot of risk on the firms, since not everything is under their control, and that’s expensive and difficult to contract for and monitor. Thus, we advocated for push funding to de-risk capacity construction for the firms. Capacity construction is well understood–double this line–and thus much easier to contract for and monitor. (Contracting on capacity is also cheaper than a traditional AMC for reasons explained here and also in my discussion with Tyler here.) The nice thing about buying capacity is that it changes the dynamic from one where countries are scrambling to buy before others do to one where early purchases increase capacity that is later available for everyone. OWS, to its credit, did fund capacity construction for Moderna but we wanted more and other governments didn’t step up to the plate.

OWS has been a success. In combination with investments from other governments and organizations like CEPI it will save trillions of dollars and many lives. It could have been better but the main takeaway is that the case for going big is still strong. We have solved the scientific problem of making the vaccine but step two is getting billions of doses in arms. If we can increase capacity enough to vaccinate millions more people next year than currently planned that would still pay for itself many times over. Increasing capacity is not impossible. China is increasing capacity for its vaccines. It will be harder to increase capacity for mRNA vaccines since the technology is new and bespoke but it can be done. We need a second Operation Warp Speed, OWS: Delivery and Distribution.

As Tyler said yesterday, Williams wants a cow! We want billions of vaccine doses quickly. It can be done, it should be done.