“This is all about patients,” Dr. Susan Alpert, Medtronic Inc.’s top regulatory officer, told Food and Drug Administration officials Tuesday at a town hall meeting in Bloomington, Minnesota.
But was it? For all of the venture capitalists, CEOs, doctors, and industry consultants Minnesota’s medical device community threw at Dr. Jeffery Shuren, there was not one patient to tell the FDA’s new device chief that the agency’s overzealous regulatory impulse was hurting the quality of healthcare.
Instead, there was plenty talk of failed start-ups, diminished returns, and fragile economies should the FDA not change its overcautious ways or mess with the popular 510(k) approval program. There were plenty of people who claimed to speak for patients. But oddly no patients.
Behavioral Health, Interoperability and eConsent: Meeting the Demands of CMS Final Rule Compliance
In a webinar on April 16 at 1pm ET, Aneesh Chopra will moderate a discussion with executives from DocuSign, Velatura, and behavioral health providers on eConsent, health information exchange and compliance with the CMS Final Rule on interoperability.
If the medical device community feels defensive these days, it’s partly their fault. Faced with a Congress and staff scientists who question the FDA’s commitment to safety, the industry has only now begun to mobilize. But the industry’s most glaring error is a tone deaf communications strategy (if you call it a strategy) that seems almost impervious to public perception.
Medical device officials vaguely speak of patient welfare (after all, they are the customers). But listening to speaker after speaker drone on about profits, risk evaluation, and various regulatory mumbo jumbo (“creeping predicates” was my favorite), you would think this was a Medtronic convention, not a town hall meeting open to the public.
That’s not to say the economic stuff is trivial. This is Minnesota after all, where medical device companies employ more people per capita than anywhere in the United States. But as some speakers noted, the FDA’s mission is to protect safety and promote innovation, not preserve Minnesota’s bread and butter industry.
Rather than embrace humility and empathy, the medical device community has pursued an all out blame game: the news media for hyping product recalls, politicians for undermining doctor/industry relationships, FDA examiners who ask irrelevant questions and lack basic expertise in the field.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
All that may be true. But the FDA, like any high profile government agency, does not operate in a politics-free bubble. Dr. Shuren has people he must answer to. The medical device community has failed to respond to or even understand the populist impulses that convince people, often without merit, that the FDA is somehow not looking after Joe Patient.
Take Wall Street. Investment banks play a key role in the economy but the public vilifies them partly because they do not understand what they do and why it matters. When Goldman Sachs CEO Lloyd Blankfein recently proclaimed he was “doing God’s work,” I’m sure his PR folks nearly fainted.
Dr. Shuren seems to grasp this. He was diplomatic, thoughtful, and often funny. He managed to say a lot without really saying anything at all. And somehow, you felt better.
When a consultant handed him a proposal to fix the FDA, Dr. Shuren repiled: ‘I guess I won’t be reading the new Nora Roberts novel on the flight back home.”
Even his humor betrayed some subtle insight. Medical device officials often complain that the agency’s staff scientists are really running the show, that top FDA officials are afraid to overrule their subordinates.
“Thank you for getting to your seats so quickly,” Dr. Shuren told the audience after a short break. “And I only had to ask once. At the FDA, my own staff routinely ignore me.”
