Research Programs
More
What are you looking for?
Showing 9 of 131 Results in Health Care
Popular Media A California state appellate court on Jan. 9 affirmed in Gilead Life Sciences, Inc. v. Superior Court of San Francisco the creation of a novel corporate tort, holding a . . .
A California state appellate court on Jan. 9 affirmed in Gilead Life Sciences, Inc. v. Superior Court of San Francisco the creation of a novel corporate tort, holding a firm liable for negligence for failing to develop and market a product superior to the firm’s current product on the market.
Read the full piece here.
TOTM The National Institute for Standards and Technology (NIST) published a request for information (RFI) in December 2023 on its “Draft Interagency Guidance Framework for Considering . . .
The National Institute for Standards and Technology (NIST) published a request for information (RFI) in December 2023 on its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.” It’s quite something, if not in a good way.
TOTM The Federal Trade Commission (FTC) has now gone on record in comments to the National Institute of Standards and Technology (NIST) that it supports expanded “march-in rights” . . .
The Federal Trade Commission (FTC) has now gone on record in comments to the National Institute of Standards and Technology (NIST) that it supports expanded “march-in rights” under the Bayh-Dole Act (Act). But if NIST takes the FTC’s (unexpected, but ultimately unsurprising) contribution seriously, such an expansion could lead to overregulation that would ultimately hurt consumers and destroy the incentives that firms have to develop and commercialize lifesaving medicines.
Popular Media When 194 countries meet in May for the annual World Health Assembly, the World Health Organization (WHO) intends to push health ministers to sign a . . .
When 194 countries meet in May for the annual World Health Assembly, the World Health Organization (WHO) intends to push health ministers to sign a pandemic treaty. Granting the WHO this power risks spurring a new pandemic.
The WHO got a lot of policies wrong on COVID, many of which would effectively be codified in the new treaty. The agency pushed lockdowns and vaccine and mask mandates and promised vaccines would prevent transmission. It consistently failed to show interest in key issues like COVID’s origin or how Sweden achieved such remarkable outcomes — notably half the U.S. death rate — without these draconian measures. And it foolishly believed China would be transparent with its data and control the virus.
TOTM Five months from now, health ministers from the 194 sovereign states recognized by the United Nations (UN) will meet in Geneva to discuss and possibly . . .
Five months from now, health ministers from the 194 sovereign states recognized by the United Nations (UN) will meet in Geneva to discuss and possibly agree to amendments to the International Health Regulations (IHRs), which are intended to “prevent, protect against, prepare, control and provide a public health response to the international spread of diseases.” Ministers will also be asked to approve the text of a new World Health Organization (WHO) convention to combat future pandemics.
While there is a need to coordinate the detection of and response to potential pandemics, it is not clear what role, if any, the WHO should have. Perhaps more importantly, it is uncertain what policies should be put in place (and by whom) to prevent, limit, and respond to any future pandemic. The U.S. government should encourage the WHO to delay both changes to the IHRs and the introduction of a new treaty until several issues are satisfactorily resolved.
TOTM This post discusses three important problems with the Food and Drug Administration’s (FDA) accelerated-approval process. The first is that regulatory authorities and patient groups maintain . . .
This post discusses three important problems with the Food and Drug Administration’s (FDA) accelerated-approval process. The first is that regulatory authorities and patient groups maintain that, legally, the standards of accelerated approval are the same as standard approval. Yet from a risk perspective, the standards are quite different; by shifting risk taking from regulator to patient, physician, and payer, this creates problems. The second problem is more practical and is generally considered the most significant problem with accelerated approval. Some companies that have received accelerated approval for their products have not done confirmatory studies, as required by their agreement with FDA. This leads to distrust of these companies and their products, and threatens to undermine the accelerated-approval program. The third problem is the issue of approving medicines with marginal benefits.
TOTM In my most recent post on medicine approvals I explored how the HIV/AIDS crisis drove a reevaluation of what was truly essential to demonstrate a new drug’s . . .
In my most recent post on medicine approvals I explored how the HIV/AIDS crisis drove a reevaluation of what was truly essential to demonstrate a new drug’s efficacy. Allowing HIV patients to take investigational treatments meant that research into rarer conditions—which previously would never have been profitable—might now be financially worthwhile.
This post estimates the benefits of accelerated approval and how oncology medicines have become the treatment category with the most accelerated approvals.
TOTM In the headline to a Dec. 7 press release, the Federal Trade Commission (FTC) announced that it, in concert with the U.S. Justice Department (DOJ) and . . .
In the headline to a Dec. 7 press release, the Federal Trade Commission (FTC) announced that it, in concert with the U.S. Justice Department (DOJ) and U.S. Department of Health and Human Services (HHS), had managed to “Lower Health Care and Drug Costs, Promote Competition to Benefit Patients, Health Care Workers.” According to the subhead: “Recent agency actions have helped lower costs, increase care quality for consumers and promote competition across the health care market.”
The headline sounds great. One wonders about the extent to which the subhead is true.
TOTM This is the second post about the U.S. drug-approval process; the first post is here. It will explore how the Food and Drug Administration (FDA) arose, . . .
This is the second post about the U.S. drug-approval process; the first post is here. It will explore how the Food and Drug Administration (FDA) arose, how disasters drove its expansion and regulatory oversight, and how the epidemic of the human immunodeficiency virus (HIV) changed the approval processes.
