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Today’s #FDA #SundayTweetorial is personal. I look back at what we've accomplished at FDA to advance innovations to benefit patients, promote policies to protect consumers, and address public health challenges during the two years I've shared these experiences with my colleagues.
I was truly fortunate to arrive at #FDA at an inflection point in medicine, health, and science – during a time when new discoveries, made right down to the molecular level, offer the potential to transform health, protect consumers, and cure disease in fundamentally novel ways.
Each novel medical technology challenged #FDA to be nimble and creative in its approach to product evaluation so that innovation would not only advance efficiently to benefit patients but do so while strengthening the agency’s gold standard for safety and effectiveness.
Working together, FDA's professional staff succeeded in achieving that balance, time and again. Consider gene therapy go.usa.gov/xEJPB. Researchers had spent decades seeking a way to insert a gene into a patient’s cell instead of using drugs or surgery to address disease.
In August 2017, #FDA approved the first gene therapy product go.usa.gov/xEJQd and later two others go.usa.gov/xEJQt; go.usa.gov/xEJQH. To further encourage innovation, we issued product specific guidance and manufacturing guidance go.usa.gov/xEJmF.
We also advanced a novel framework for the modern and efficient regulation of regenerative medicine; for enabling the prospect of cell and tissue engineering to grow healthy, functional cells, tissues and organs to replace diseased or damaged ones go.usa.gov/xEJU3
And with diseases being redefined based on molecular subtype, we took steps to modernize our evaluation of the development process for targeted drugs and devices that are intended to deliver the right drug and device to the right patient at the right time go.usa.gov/xEhae.
Our modernization steps included encouraging clinical trials to be more efficient and potentially less costly by supporting patient-centered endpoints and such innovative trial designs as seamless trials, master protocols and basket trials go.usa.gov/xESXe...
…. flattening our review process, breaking down silos to make our review process more standardized and efficient go.usa.gov/xESRM, lessons learned from our Oncology Center of Excellence go.usa.gov/xESRe
…and working to harness real-world evidence, including data captured from sources such as electronic health records; registries; and claims and billing data to support regulatory decisions go.usa.gov/xEhjV.
We also forged a new breakthrough pathway for novel devices go.usa.gov/xEJUf; undertook new steps to modernize the 510(k) process go.usa.gov/xEJUt; advanced new approaches for efficiently regulating personal genetic tests go.usa.gov/xEJPr...
…and introduced the Pre-Cert concept, a potential regulatory program for mobile apps and medical devices connected digitally to medical tech, that's better suited to these technologies that receive continuous software updates. We’re currently piloting it go.usa.gov/xEh56
These many efforts to modernize our approach to innovation have had a positive public health impact over time. #FDA approved a record number of novel drugs and novel devices in 2017; then we set new records in 2018, including approving the most drugs ever for targeted therapy.
But patients can’t benefit from new medical innovations if they can’t afford them. We’ve worked hard to facilitate robust and timely market competition for lower-cost generic drug products go.usa.gov/xEh8x and biosimilar and interchangeable products go.usa.gov/xEhXA
We’ve streamlined the submission and review process for both generics and biosimilars, facilitated the development of complex generics, and pursued policies to stop gaming by brand manufacturers that sought to extend drug monopolies beyond the time that Congress had intended.
And the results bear out these approaches. In 2018, we approved or tentatively approved more than 1,000 generic drugs with record-breaking highs in October and November. First generics accounted for nearly 10% of approvals; and complex generics for 14% go.usa.gov/xEJPR.
Other parts of #FDA are adapting to cutting-edge technology as well. Consider the promising new technologies that can edit animal and plant genomes with the potential to improve human/animal health, food productivity, animal well-being and food security go.usa.gov/xEJPG.
Our Action Plan advances policy priorities we’ll pursue to clarify our science-and-risk-based approach for product developers; avoid unnecessary barriers to innovation in plant and animal biotechnology; and advance safety and our public health mission go.usa.gov/xEhDZ.
In the past two years, we’ve also taken a hard look at where else we can advance innovation and improve consumer protection across our vast portfolio. Our efforts related to cosmetics - which are still regulated under an 80-year-old law - is one example of this broader effort.
The law focuses on ensuring that cosmetics are safe when properly labeled and used according to the label – #FDA does not review or approve cosmetics and their ingredients prior to sale, except color additives go.usa.gov/xEGJC.
Amid concerns about asbestos in cosmetics, we recently called on the cosmetic industry to take important new steps and to work with us to improve our overall framework for assuring the safety of cosmetic products. go.usa.gov/xEJmS.
#FDA also has efforts underway to bring oversight of the exploding dietary supplements market into the 21st Century. Our current initiatives are aimed at protecting the public from bad actors without burdening responsible companies go.usa.gov/xEhjC.
One area where #FDA can have a profound, generational, and transformative impact on human health - outweighing any single medical innovation or intervention that we could discover - is through advances in nutrition and diet.
Poor nutrition plays a role in heart disease, cancer and obesity and yet about 75% of the population has a diet low in vegetables, fruits, dairy and healthier oils; and most Americans exceed the recommended intake of added sugars, saturated fat and sodium go.usa.gov/xEhba.
Our 2018 Nutrition Innovation Strategy go.usa.gov/xEJA5 seeks to reduce preventable death and disease caused by poor nutrition by ensuring that consumers have accurate useful info to make healthy food choices and also by fostering the development of healthier food options.
The Food Safety and Modernization Act of 2011 (FSMA) greatly enhanced #FDA’s ability to fulfill its critical role of protecting the food supply through an emphasis on preventing risk. During my tenure we’ve worked hard to implement #FSMA go.usa.gov/xEhXH
Over the past two years, we’ve also supported a number of major legislative efforts: To secure a more modern framework for the efficient regulation of diagnostic tests go.usa.gov/xEJ6B, to reform how over-the-counter drugs come to market…
...and to reauthorize two animal drug user fee programs that enhance our ability to maintain a predictable, timely animal drug review process, foster innovation in drug development, expedite access to new therapies for food-producing and companion animals go.usa.gov/xEhXJ
Antimicrobial resistance occurs when microbes (e.g., bacteria, viruses, fungi) resist a drug - they aren’t killed/their growth isn’t stopped, so we lose our ability to effectively treat these infections. Addressing it requires an all-hands on deck, multi-faceted initiative.
FDA’s 2019 Strategic Approach for Combating AMR calls for fostering product development; supporting antimicrobial stewardship; enhancing AMR surveillance/monitoring; and advancing regulatory science to facilitate product development go.usa.gov/xEhkN.
I’m proud of how #FDA has stood strong in moments of crisis during the two years we worked together; leading a global investigation into impurities found in angiotensin II receptor blocker (ARB) drugs used to treat high blood pressure and heart failure go.usa.gov/xEJ6F...
…dedicating ourselves to mitigating the drug and device shortages in the aftermath of the storm in Puerto Rico go.usa.gov/xEh5H; and maintaining critical functions and protecting the public during an historic government shutdown go.usa.gov/xEh5F among other moments
But our most vexing public health challenges remains the crisis of addiction to opioids and addiction to nicotine. Let’s look at opioids first, the largest and most complex public health tragedy our nation has ever faced, requiring decisive new steps by #FDA, on multiple fronts.
We’ve been working to prevent new opioid addiction; support treatments for opioid-use disorder and greater naloxone access; advance innovation in less risky non-opioid pain drugs; and increase enforcement/interdiction of illegal drugs go.usa.gov/xESEF.
Companies that market opioids are now required to offer robust training on the safe prescribing of these products to all health care providers – it has also been broadened to include immediate-release in addition to extend-release, long-acting opioids go.usa.gov/xESEy
To jumpstart development of an over-the counter version of life-saving naloxone, which reverses an opioid overdose, FDA did unprecedented work - developing a model Drug Facts Label that sponsors can use to obtain approval to make naloxone OTC. go.usa.gov/xESEU
Owing to 2018 SUPPORT Act, we'll now require short-duration packaging for outpatient dispensing and are implementing authority to more easily detain, refuse and destroy illegal and dangerous drugs, including opioids, at our 9 International Mail Facilities go.usa.gov/xPE3r.
Opioids are different from other drugs, raising a host of other issues because of their abuse potential. Under our watch, for the first time FDA took steps to remove a currently marketed opioid from sale due to the public health consequences of illicit use go.usa.gov/xEJVU
And just last week I told Congress that #FDA needs a new standard for future approvals of new opioid drugs to ensure they offer a comparative advantage over existing opioids already approved to treat the same condition go.usa.gov/xESmn.
#FDA has also advanced impactful policies regarding the regulation of tobacco and nicotine. The cornerstone of our new comprehensive plan go.usa.gov/xESWY has been a proposal to lower nicotine in cigarettes to a minimally or non-addictive level.
Lowering nicotine levels in cigarettes this way could decrease the chances that future generations become addicted to them and make it easier for currently addicted smokers to quit. One possible policy scenario estimated staggering public health benefits go.usa.gov/xESWk.
I am deeply committed to preventing youth access to all tobacco products, including e-cigarettes. We’ve taken a series of actions to halt the public health epidemic of youth e-cigarette use, which threatens to hook an entire generation of kids into a lifetime of addiction.
Responding to the steep rise in youth e-cig use we issued 1,300+ warning letters and fines to retailers who illegally sold e-cig products to minors go.usa.gov/xPbCy and targeted e-liquids featuring misleading, kid-appealing labeling and advertising go.usa.gov/xEh8e
FDA also launched “The Real Cost” E-cigarette Prevention Campaign to educate teens about the potential risks of e-cigs, urging them to “know the real cost of vaping” and joined forces with @Scholastic to ensure all 37k+ U.S. high schools receive youth vaping prevention posters.
@Scholastic New draft guidance issued this month discusses ways to limit youth access to and appeal of flavored e-cigs, such as heightened age verification, sales only in locations that minors are not able to enter at any time, and quantity limits for online sales go.usa.gov/xEhBP
@Scholastic FDA made great strides protecting and promoting public health the past two years, thanks to the dedication and scientific prowess of our talented workforce. While this is my last week at FDA, I’m confident in the future, and proud to have shared these and other efforts with them.
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