- | Healthcare Healthcare
- | Expert Commentary Expert Commentary
HHS’s ‘Sunset Rule’ Will Save Money and Lives
HHS's new rule has caused plenty of anxiety, but allowing outdated regulations to expire shouldn't be controversial. Read more
- | Regulation Regulation
- | Policy Briefs Policy Briefs
The Benefits of HHS’s SUNSET Regulation
On January 8, 2021, the US Department of Health and Human Services (HHS) announced that it would be finalizing a regulation
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HHS Shows How to Sunset Red Tape on Small Business
The new HHS rule isn't a radical change, but it is a step in the right direction. Read more at The Hill.
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- | Public Interest Comments Public Interest Comments
HHS’s Innovative New Sunset Regulation
Background on the RuleThe Department of Health and Human Services (HHS) is proposing a regulation that would build sunset
- | Healthcare Healthcare
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To Boost Vaccination Rates, Empower Pharmacy Technicians
When we finally do get a vaccine, we can make sure more people get it in less time by getting rid of pharmacist-to-technician
- | Healthcare Healthcare
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Seniors Suffer the Most From Antiquated FDA Approval Process
The FDA's risk aversion costs lives, but the Japanese process for drug approval offers a solution. Read more at The Hill.
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Trump Is Winning the Vaccine Debate With Public-Health Experts
If the FDA is too proud to engage in the political debate over vaccine policy, their warnings will be ignored. Read more at
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A Cocktail for COVID Relief
During this pandemic, we could all use a beer or two, but the new federal dietary guidelines (based on bad data) tell us to stop
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In This Weary World of Woe, Couldn't We at Least Have a Second Drink?
During this pandemic, we could all use a beer or two, but the new federal dietary guidelines (based on bad data) tell us to stop
- | Healthcare Healthcare
- | Policy Briefs Policy Briefs
FDA Drug Review Reforms
The High Cost of Current FDA Drug Review PoliciesOn average, it takes 466 days for a new drug to be approved for marketing by
- | Healthcare Healthcare
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Regulators Wonder if Cancer Patients ‘Need’ New Treatments
Matthew D. Mitchell and Anna Parsons write on regulatory hurdles faced in introducing a new cancer drug, despite the drug
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Can We Have Our Insects and Eat Them, Too?
Richard Williams writes on a potential future of eating insects.Read it at RealClear Policy.
- | Regulation Regulation
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Regulators must first admit defeat on nutrition labels to improve
Richard Williams writes on the need to reform food nutrition labels, much as Canada has recently done.Read the article on The
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As Free Innovation Encounters Health Care Regulation, Think ‘Soft Laws’
The concept of free innovation has entered the technology lexicon, particularly when it comes to health care. The term refers to
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No, Medicare for All Won't Lower Health-Care Costs
Since Charles Blahous' study on the costs of Senator Sander's "Medicare for All" plan was published, several key aspects of the
- | Regulation Regulation
- | Policy Briefs Policy Briefs
Focused Mitigation Strategies to Protect Food against Intentional Adulteration
The proposed “Focused Mitigation Strategies to Protect Food against Intentional Adulteration” rule is intended to supplement four previous bioterrorism rules to reduce the probability of a successful terrorist act involving processed food.1 Congress mandates an essentially redundant regulation while paying no attention to the identified threat of intentional contamination through the mechanism of foot and mouth disease, which could cost the US economy in excess of $10 billion.
- | Regulation Regulation
- | Public Interest Comments Public Interest Comments
Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act
This public interest comment estimates the range of annual benefits (costs avoided) associated with e-cigarette use as $15.6 billion to $49.2 billion and that 2.4 million to 6.4 million smokers may potentially become ex-smokers by using e-cigarettes. Estimates are based on a range of quit rates from the current literature and assume all smokers interested in quitting use e-cigarettes. Even a fraction of estimated benefits (costs saved) are substantial. These estimates indicate the FDA is jeopardizing public health by not estimating benefits associated with e-cigarettes using data from readily available studies on their efficacy as harm-reduction tools.
- | Public Interest Comments Public Interest Comments
Food Labeling: Revision of the Nutrition and Supplement Facts Labels
Pursuant to the Nutrition Labeling and Education Act (NLEA) of 19901 and the Dietary Supplement Health and Education Act (DSHEA) of 1994,2 the Food and Drug Administration (FDA) issued regulations requiring food and dietary supplement products to display labels declaring their nutrient content. The regulations specified the format for nutrition labeling as well as the reference values to use in declaring the nutrient content.
- | Public Interest Comments Public Interest Comments
Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One-Eating Occasion; Dual-Column Labeling; Updating, Modifying, & Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; & Technical Amendments
The Nutrition Labeling and Education Act of 1990 (NLEA) gives the FDA authority to regulate information displayed on food products and describes how a lack of certain types of information would be considered misbranding.1 Two rules, sharing one preliminary regulatory impact analysis (PRIA),2 have been proposed based on the authority granted by NLEA.3 The first rule covered by the PRIA, titled “Food Labeling: Revision of the Nutrition and Supplement Fact Labels” (NPRM1), includes a laundry list of potential changes that are designed to “assist consumers in maintaining healthy dietary practices.”4 The changes required are numerous and involve changes to labels, increases in recordkeeping, and new analytic requirements.
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- | Policy Briefs Policy Briefs
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
The Food Safety Modernization Act, signed in 2011, directs the Food and Drug Administration (FDA) to adopt regulations requiring facilities that manufacture, process, pack, or hold food, including animal food, to implement preventive controls to ensure that the food is not “adulterated,” as defined in section 402 of the Food, Drug, and Cosmetic Act.