W

ASHINGTON — Has President-elect Donald Trump put a bull’s-eye on the Food and Drug Administration?

It’s been less than a year since Dr. Robert Califf was sworn in as the FDA’s chief, but already the agency is facing post-election upheaval. Public health advocates are bracing for a seismic shift: a surrender of the agency’s rules for off-label promotion of drugs; the importation of more drugs from other countries; and fewer requirements for clinical trials — long the gold standard for determining whether medicines are safe and effective.

“Between a Trump presidency and a radically pro-business Congress, the next few years may see a removal of numerous consumer protections,” said Michael Jacobson, cofounder and president of the Center for Science in the Public Interest.

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For Trump and his advisers, including Newt Gingrich, the agency has for too long acted as a barrier to medical innovation.

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Gingrich, the former speaker of the House, has previously described the FDA as the nation’s leading “job-killer” and called for its abolishment. “The FDA is a major prison guard stopping the breakout in health,” he wrote in the National Review in 2013.

The FDA’s balancing act between patient protection and the drug and device industry’s push for a quicker path to market has never been easy. But Califf, who had close ties to the pharmaceutical industry before his career at the FDA, has said there’s good reason.

“Unfortunately, too many of the decisions made today about health and health care are not supported by high-quality evidence, because there is such a limited amount available,” he said in a speech last May to the Food and Drug Law Institute.

“The current deficit in evidence has become particularly acute for the FDA, which in numerous areas lacks vital evidence needed to support definitive regulatory determinations of safety, efficacy, and appropriate indications for marketed medical products,” Califf told the group.

Over the past few years, spurred by patient advocacy groups and much of the pharmaceutical industry, lawmakers have fought over a package of bills that would clear the path for a major shift in the way the country regulates prescription drugs and medical devices. Regardless of whether that legislation advances, Trump’s presidency is likely to enable the industry to get much of what it wants in terms of deregulation.

“I’ve talked to lots of folks in medical devices, pharma over the last several days. They are certainly, number one, breathing a sigh of relief,” said former Republican Representative Mike Ferguson, who is director of the federal policy at BakerHostetler and is close to the Trump transition team. “They were preparing themselves to have to go to battle with a Clinton administration that was very hostile to them.”

In a report to its clients, Holland & Knight, a law firm with a major health care practice, noted FDA staffers were particularly worried about the possibility that Trump would expand controversial “Right to Try” rules, which allow terminally ill patients to access unapproved therapies that have passed basic safety testing.

“At the very least, President-elect Trump will support ‘Right to Try’ laws that attempt to provide access to unapproved drugs,” the authors wrote. “Vice President-Elect Mike Pence supports a Right to Try law in Indiana as governor and advocated for it during the campaign.”

The FDA does have a program known as “compassionate use,” which grants access to unproven treatments outside of a randomized clinical trial. Although the agency grants nearly all such requests, it has also been wary about the “Right to Try” movement, which has been successful in 31 states, and leaves questions about whether the states have authority over the FDA — a prospect agency staffers do not welcome.

One former FDA official, who spoke on condition of anonymity to speak candidly, said support for the “Right to Try” movement signals a broader disapproval of regulation.

“The people who believe in that don’t believe there should be an FDA,” the former official said.

Trump has also vowed to remove barriers allowing easier entry into the United States for drugs made overseas — which would be difficult since the FDA is already having trouble monitoring the drugs that are coming in now.

Much of the FDA’s work, of course, focuses on food. Early on in the campaign, Trump expressed distain at FDA’s food safety regulations.

“The FDA Food Police, which dictate how the federal government expects farmers to produce fruits and vegetables, even dictates the nutritional value of dog food,” Trump said in a September speech. “The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperature and even what animals can roam which fields and when.”

Jacobson, of the Center for Science in the Public Interest, said “it’s hard to know how seriously to take it.”

But he also said Congress could easily cut the FDA’s budget, thereby “crippling programs to prevent food-borne infections, prevent dishonest food labels, and keep unsafe additives out of the food supply.”

Others said even if he intends to overhaul the FDA, Trump may be surprised to find there are limits to what he can do.

“You can be against regulation all you want, but the Food, Drug and Cosmetic Act is not something that is malleable within executive orders,” said Dr. Sidney Wolfe, founder and senior adviser to Public Citizen’s Health Research Group, which has long battled the agency for better patient protection. “There are laws, many laws, and it took a long time to get them.”

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  • The problem is that people now have the opportunity to regrow damaged and missing teeth! All thanks to the Dr. Jeremy Mao at Columbia University. People go threw painful procedures of root canals, implants etc. Mr. Jeremy Mao has invented a way for that to change forever! We want that chance. We are calling out dental companies, associations and stem cell research centers to allow Mr. Jeremy Mao the opportunity to move forward with clinical trials of his work. This work was founded in 2010 and in 2013 clinical trials were supposed to be done so the public can receive this dental procedure. It 2016 and we the people know that the American dental association and Dental companies along with clinical trials centers themselves are trying to stop this doctor’s work and other doctors from allowing his work to reach clinical trials and then to the public. We must demand our opportunity! Yes we can! This will help people all over the nation and across the world! Giving people confidence to be courageous and social and never have to live in depression ever again. Giving people a 3rd chance at a Beautiful valuable real smile. For ourselves, our brothers and sisters, our mother and fathers and our grandparents who all lost teeth and have to live with the artificial crowns or implants let’s stop this and regrow our teeth with stem cell teeth regeneration.We need the FDA’s approval to go Forward! Everyone please contact them anyway you can and tell them we want this approved or we take it above them for putting profit over human health!

  • Yes, the FDA may be crucial in patients protections against dangerous unapproved drugs but it also seems to have double standards take for instance the delayed tooth regeneration clinical trials for Dr Jeremy Mao of Columbia University Dental department that’s seems to be due to powerful dental companies manufacturing fake unsustainable dental materials that have health and inconievences to its uses. This is where FDA seems to have a problem and their seem to be powerful people controlling it from the outside. It needs to be examined and investigated well to. Thanks and waiting for response please via my mail

    • What a news! I followed all the news about the J. Mao progress in regenerating tooth in a natural way until the end of 2015. Suddenly no news in 2016. Now I can understand why but I’m not surprised. The Jeremy Mao technique is so disruptive for the dental industry. But this block from FDA is unacceptable. All the humans need of Mao research. Hoping in a turnaround.

  • Dr. Califf is little better than a front man for Monsanto! At least five phone calls and six months later, he can’t be bothered to return a call concerning health issues with our food supply.

  • A small company in Washington DC called Bioelectronics which makes a medical device called, the Actipatch. This device is being sold in 50 countries to reduce / eliminate pain, swelling and inflammation. This company has been held back by the FDA in our own country for so many years. This device has no drugs nor side effects with over 1 billion logged treatment hours. The amazing part is, it works, for 30 dollars a month. Speaking to various people in approved countries where the devices are sold over the counter, pain meds are reduced or eliminated. I have no faith is this FDA administration.

    Best wishes

    Kent

    • Does it stimulate the vagus nerve? Vagal nerve stimulation is fascinating, and I wish the company the best of luck with their product. You do realize though, that the situation that you’re referring to is unusual, right? Most drugs have side-effects. Most drugs have DEADLY and DISABLING side-effects, some of which are transgenerational. It is appropriate to regulate those drugs and ensure that they are safe and used appropriately.

  • If Gingrich is so focused on providing innovation and reducing barriers why doesnt he go after Monsanto and other predatory practices by patent holders who constrain small business owners and farmers

  • I can think of nothing better than to reboot the FDA’s device unit, and blow up the dental unit entirely. Clearly the Consumer Product Safety Commission or the National Highway Traffic Safety Board would give consumers – patients and parents – a warning label that dental amalgam contains 50% mercury that off-gases with heat and abrasion. Mercury vapor is a neurotoxin that harms fetuses, children, those with common gene types that do not methylate (clear heavy metals and toxins) well as they age, and people with neurological, autoimmune, autonomic cardiovascular, dermatological, kidney, and respiratory diseases – as well as memory, mood and mental status changes – which mercury causes. Why is there no patient label, or written informed consent required by patients or parents? Why does the FDA sit on its own draft 2012 Patient Safety Warning on Dental Amalgam? Why does the FDA recommend patch testing before using hair color – but no biocompatibility testing before having dental or medical devices installed in the body 24/7/365 – especially when they contain neurotoxins that are considered hazardous waste before installation, and after removal? The findings of amalgam safety from the Children’s Amalgam Trial have been retracted by James S. Woods et al in four journal articles 2011-2014 available in PubMed. The agency’s device unit – and especially the dental products unit – is trapped in a web of regulatory failure, inertia and capture.

    Congress has not acted – nor any Administration since JFK first proposed regulating medical devices in 1962 – to take the bolder steps needed to improve medical and dental device safety. These would include prescreening patients for biocompatibility before receiving any device, written informed consent with written information to patients like we get for prescription drugs, OTCs and personal care products, and removing the figleaf of PreMarket Approval so harmed patients have recourse and are able to remove and replace devices that are not “right for them” and recover their health. Currently these costs are borne by individuals, families, employers, health plans, and government. Dental insurance is a joke with no medical necessity and no recourse, and only covers the cheapest FDA-approved products like dental amalgam outside of the front teeth for cosmetic reasons – where few people get cavities.

    On the anniversary of JFK’s tragic death, FDA’s leaders should stand up for patients’ health and safety over industry profits and patents, especially with regard to medical and dental devices – stat. Show the rest the door.

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