Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Monday, March 11, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on Administration’s request for new FDA funding to continue to advance robust regulatory framework for oversight of e-cigarettes, prevent youth access and initiation; and harness innovation to advance the safety of food, compounded drugs, U.S. blood supply
For Immediate Release
March 11, 2019
The U.S. Food and Drug Administration holds critical responsibilities for ensuring the safety, effectiveness and security of human and animal drugs, biological products and medical devices; as well as ensuring the safety of our nation’s food supply, cosmetics and radiation-emitting products; and regulating tobacco products. Advances in medical science, product manufacturing, nutrition and digital technologies give us new ways to advance our mission to protect and promote public health, delivering more of the benefits of innovation and market competition to patients in a safe and timely manner. These same opportunities give us additional tools to secure our fundamental consumer protection mission.
Leveraging these opportunities requires us to make ongoing investments in regulatory science that can protect patients and consumers, while also reducing uncertainty for innovators through modern, risk-based regulatory standards; spur investments in new industries and technologies that can improve the health of patients and consumers; secure the safety of food products; and promote competition through more affordable generic and biosimilar products, expanding patient access to effective treatments.
Toward these goals, the FDA’s budget request of $6.1 billion as part of the President’s Fiscal Year (FY) 2020 budget includes a requested increase of more than $643 million compared to the 2019 Annualized Continuing Resolution (CR) (or $419 million compared to the FY 2019 Enacted Budget) to support urgent public health priorities and help support our core consumer protection mission. This includes more than $220 million to continue advancing new initiatives that will promote medical product innovation.
I want to provide some highlights on some of the high priority initiatives that we seek to fund.
Among the goals that we plan to pursue through these resources: These additional funds will help the agency combat the opioid epidemic; advance new steps to support the production of quality compounded drugs; expand the FDA’s capacity to review human food and animal feed ingredients; and continue implementation of the 21st Century Cures Act to advance patient-centered medical innovations.
Funded programs will also improve food safety and provide consumers with greater information about healthy food choices using the most up-to-date science, modernize our oversight of dietary supplements and advance new innovations to improve the safety of the U.S. blood supply.
Importantly, the budget also seeks $100 million in new tobacco fees, and includes manufacturers and importers of deemed tobacco products, in particular and especially electronic nicotine delivery systems (ENDS), and certain other products within the FDA’s tobacco user fee assessments. e-cigarettes, in particular, represent an increasing share of the tobacco marketplace. The new resources will support the FDA in its continued efforts to create a modern regulatory framework for the appropriate oversight of e-cigarettes and in taking continued steps to reduce youth use of all tobacco products. One of our most important public health efforts is to continue standing up a framework to make sure we can put e-cigarettes through an appropriate series of regulatory gates, and aggressively confront youth use of these products to make sure children don’t become addicted to nicotine.
The agency strives to continually strengthen our capacity for using modern regulatory science and efficient, risk-based decision making to advance our public health mission. The investments and commitments we’ve outlined in our FY 2020 budget will help the FDA advance our shared public health goals, meet current and emerging public health challenges and harness the full potential of precision medicine and digital technologies to improve health and reduce the burden of serious chronic illnesses.
Here's a closer look at some of the key initiatives and investments that we plan to pursue through both the FY 2020 budget request and the FY 2019 funding provided by Congress in February:
Reducing the burden of addiction crises facing families and communities, including new efforts to advance FDA’s modern regulation of e-cigarettes and prevent youth initiation to nicotine
The opioid crisis is one of the largest public health tragedies that our nation has ever faced and, despite recent reductions in fatal overdoses in some states and reductions in the prescribing of opioids that could translate into reduced rates of new addiction, it remains the largest public health crisis facing the FDA.
The FDA continues to advance activities to stem and reverse the opioid epidemic through four key priorities: First, our primary goal is to decrease unnecessary exposure to prescription analgesic opioids and, in turn, reduce the rate of new addiction. We’re pursuing this goal through a broad range of efforts, including through evidence-based prescribing, and also steps to reduce the amount of excess opioid analgesics available for diversion. At the same time, we’re focused on helping individuals with opioid addiction return to lives of sobriety through access to effective medication assisted treatment (MAT), and reducing the stigma associated with the use of MAT. We’re also facilitating development of novel non-opioid alternatives that can provide important new treatment options for pain management. We’re increasing our enforcement activities to crack down on the illegal sale of opioids in partnership with Customs and Border Protection through our existing infrastructure and additional lab capacity at the International Mail Facilities, to bolster our ability to interdict illicitly manufactured opioids. Finally, we’re taking steps to crack down on the illegal sales of opioids on the surface and dark web. Our budget request helps increase our field and center operational capacity to enable review of up to 100,000 packages annually, to bolster our interdiction efforts aimed at protecting consumers from unsafe products.
The FDA is also continuing our historic efforts to reduce the death and disease associated with the use of combustible tobacco products and reduce youth use of any tobacco product. Our FY 2020 budget request seeks an additional $100 million in tobacco fees and includes manufacturers and importers of deemed products, in particular ENDS products, and certain other products within the FDA’s tobacco user fee assessments.
The FDA is fully committed to a pathway for the efficient and effective regulation of ENDS products. These products have the potential to offer currently addicted adult smokers a way to fully transition off cigarettes, but still enable them to get access to satisfying levels of nicotine, but potentially without the same risks as combusting tobacco. But the e-cigarettes must be put through an appropriate series of regulatory gates to properly assess their risks and to understand their potential to help smokers who completely switch from combustible tobacco.
For example, we have studies underway—including investigations that the FDA commissioned—to look at the potential for direct effects of harm from e-cigarettes on the lungs and other health factors that these products could negatively impact. This also includes the potential for products to cause changes that could be a precursor to cancer. We should be concerned about these potential risks and must have a regulatory program that can fully evaluate them. This is one reason why we so strongly believe that no child should be using an e-cigarette or any other tobacco product. With these new resources, we’ll continue to advance policy steps to address youth use of these products. The FDA will take action to make sure that a new generation of kids does not become addicted to nicotine through e-cigarettes. These new resources will help support these and similar efforts in pursuit of critical public health goals.
Improve food safety and opportunities to use nutrition to reduce the burden of chronic disease
Efficient global markets for food production and distribution allow American families access to a wide range of wholesome and affordable food choices that can improve their health. We want to provide Americans the benefits from access to this global market, while reducing risks from foodborne illnesses.
To advance these goals, we’re strengthening our response capabilities to foodborne disease outbreaks by improving our capacity to detect early signals associated with foodborne illness and shortening response timelines once human or animal food contamination is detected.
The Budget includes an increase of more than $16 million to improve signal detection of foodborne illness and strengthen the FDA’s response to human and animal food contamination. This will allow the FDA to identify and trace outbreaks of illness to their source and remove contaminated food from the marketplace as quickly as possible to reduce risk to consumers. We also need to make sure that consumers are quickly informed when risks are identified, and that the FDA takes swift action to reduce exposure to food that could threaten peoples’ health. To further support these efforts, we’re also implementing recent recommendations from the Office of the Inspector General for strengthening the FDA’s food recall process.
As part of our ongoing implementation efforts related to the Food Safety and Modernization Act (FSMA), the FDA also proposes allocating additional funds to provide preventive controls inspections and produce safety inspections through the state cooperative agreement programs. To advance these goals, the budget also includes an increase of nearly $16 million to support state cooperative agreements to increase preventive controls inspections and human food produce safety inspections. Our efforts will help ensure that manufacturing and processing facilities can efficiently comply with the new FSMA requirements.
Innovations in plant and animal biotechnology offer tremendous opportunities for advancing public health. Promising new technologies have the potential to improve human and animal health, animal well-being, food productivity and food security. The FDA will continue to facilitate the safe development of these emerging technologies by investing in continued enhancements to our review capabilities for biotechnology products and other novel products, assessing these products in a risk-based manner to provide predictable commercialization pathways that can foster product innovation and market access in a safe and timely way, and improve consumer nutrition. We’re also investing in premarket safety reviews of animal food ingredients to improve review times and eliminate unnecessary burdens to industry. The Budget invests $36 million above FY 2019 to provide the FDA additional capacity to review human food and animal feed ingredients. This initiative includes a proposed user fee for Innovative Food Products, which the FDA will develop in collaboration with industry and other stakeholders.
Advance the continued safety of the U.S. blood supply through new safety innovations
The U.S. blood supply is a critical national public health resource, and it is among the safest in the world. The FDA is responsible for regulatory oversight of the blood supply, including the promulgation and enforcement of standards for blood collection and for the manufacturing of blood products, including both transfusable components made from whole blood, pharmaceuticals derived from blood cells or plasma and related medical devices. The FDA also inspects blood establishments and monitors reports of errors, accidents and adverse clinical events, and works closely with other parts of the Public Health Service to establish blood standards, and identifies and responds to potential threats to the blood supply. The risk of transfusion transmitted infections, though low, nonetheless persists despite major advances in risk reduction that have been achieved by a combination of donor screening and laboratory testing.
Some of the most significant challenges can arise from new or emerging infections when we haven’t yet identified the potential pathogen, or developed and implemented screening and testing measures to mitigate the risks. There are alternatives to donor screening and laboratory testing that can potentially mitigate such significant unknown risks while offering an additional assurance of safety from known risks, and also be associated with a reduction in the screening cost for each unit of blood processed.
Pathogen reduction technologies, which are currently available for platelets and plasma, aim to improve our protection from risks posed by viral and bacterial pathogens that can be found in blood. To help advance these technologies for purposes of regulatory safety and oversight, we must implement policies encouraging the development and implementation of these innovations. The Budget includes $20 million to pilot this technology as a tool that could help eliminate contaminating viruses and other microorganisms from whole blood and still allow its subsequent separation into various blood components. This pathogen reduction technology could eventually help protect the blood supply from existing and emerging pathogens and, if successful, could potentially reduce or eliminate certain existing donor deferral and testing requirements. If this technology could be incorporated broadly, it could enhance national security by enabling a blood supply that would be safe in the face of a wide variety of emerging pathogens, and deliver these protections for a potentially lower cost than those that would be associated with current screening methods.
Strengthen the FDA’s oversight of compounded drugs to help secure patient safety
The practice of compounding medicine can provide important public health opportunities. The FDA’s compounding program—including implementation of the compounding provisions of the law—is a priority for the agency. We recognize that we must balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could cause harm. Although compounded drugs can serve an important role for certain patients whose medical needs cannot be met by an FDA-approved drug product, it’s important to understand that compounded drug products haven’t undergone FDA premarket review for safety or effectiveness. We’ve taken steps in recent years to advance this goal and we’ve shared priority areas that we’re focusing on in our 2018 Compounding Policy Priorities Plan.
To address both the need for, and safety of, compounded products, the FDA is supporting new policy development for outsourcing facilities, including efforts to improve the quality of outsourcing facilities’ compounded products. We’re also helping address providers’ needs for office stock of compounded medications. In 2020, for example, we’re standing up a Compounding Center of Excellence, to provide training programs on good manufacturing practices for outsourcing facilities, and adding a cadre of inspectors for outsourcing facilities. By engaging with outsourcing facilities and states, we can help the domestic outsourcing facility industry grow and adhere to quality standards to protect patient health, including by finalizing guidance and developing a rule for good manufacturing practices for outsourcing facilities, and evaluating hundreds of nominations for the bulks list.
The Budget provides $76 million for these and additional efforts, an increase of $25 million above the FY 2019 annualized CR level. It will support compounding activities to better inform facility, process and system design; establish a list of bulk drug substances that can be used by outsourcing facilities; increase engagement with industry to promote compliance; and help pharmacies that want to become outsourcing facilities efficiently engage the regulatory process.
We’ve made important progress in recent years on putting forth and implementing more effective compounding policies. As the FDA defines and advances these policies, we’re committed to a framework that closely aligns with our mission to protect consumers and promote opportunities to improve health.
Advancing medical product safety and innovation
The Budget also includes more than $220 million to continue advancing new initiatives to promote public health and new medical product innovation and spur growth in the domestic economy.
Among those efforts is a proposal for $55 million for an initiative to build an integrated knowledge management system and portal for medical devices to enable safety issues to be monitored, and effectiveness to be evaluated, along the total life cycle of the device. This capability to better leverage pre-existing and new data in near real time is essential for implementing the FDA’s new approaches for digital health technologies, breakthrough devices, use of real-world evidence and cybersecurity.
Overall, this will make medical device reviews, post-market surveillance and cybersecurity efforts significantly more efficient and informative. These efforts could also make medical product review cycles more efficient; allow the agency to more quickly identify and address safety signals and cyber vulnerabilities; and spur the development of innovative, safer, more effective medical devices.
New science is giving us dramatic new opportunities to improve human health and advance the choices that consumers have to improve their health and wellbeing. The FDA recognizes that we’re at an inflection point when it comes to seizing these opportunities, and we’re modernizing our policies, processes and human capital to make sure we can seize these opportunities on behalf of Americans.
At the same time, we need to confront and overcome critical public health challenges, including the opioid epidemic, poor nutrition and obesity, addiction to tobacco products and the rising cost of health care. The investments the FDA is seeking will help us meet these goals. We’re grateful for the Administration’s support of these initiatives and believe these new investments in our agency’s mission will ultimately lead both to better health outcomes for American families and to a more vibrant economy.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.