Unbiased Analysis of Today's Healthcare Issues
Right now, the answer is no, but in the near future, this may no longer be the case. The FDA has released a draft guidance on how it will regulate the new generation of wearable technology. This guidance says it will not regulate “general wellness” products like the FitBit. However, if the wearable cites health benefits for…
The Food and Drug Administration (FDA) reviews and approves all drugs. But what criteria does the FDA use to evaluate new drugs? Namely that they are effective (i.e., improve health outcomes) and safe (i.e., have limited adverse health events). In a 2007 guidance document from the FDA’s Center for Drug Evaluation and Research (CDER) and…
A number of companies, such as 23andMe, allow individuals to sequence their own genes in order to attempt to determine if they have an elevated risk for certian diseases. This sector has largely been unregulated…until now. The Economist reports, On November 22nd the FDA…sent a stern letter to 23andMe, a genetic-testing firm. Despite “more than…
Many individuals have claimed that new drug approvals are declining over time. A recent article by Lanthier et al. (2013) finds the following trends. Courtesy of Health Affairs. Drug approvals seem to be fairly steady over time, except for a decline in addition-to-class drugs. Why is this? The authors hypothesize as follows: Today we see…
When Alfred Caronia worked for a drug company, he promoted some drug’s off-label use. The Department of Justice did not take kindly to Caronia’s behavior and sued him for violating the Food, Drug, and Cosmetic Act (FDCA). He was convicted, but appealed the conviction. Caronia argued that this commercial speech is protected by the first…
In many cases, only a handful of suppliers produce vaccines for a given disease. In fact, for several vaccine types the U.S. has fewer suppliers than countries with a smaller market and a higher level of government purchase. One reason for this finding could be strict government regulation. All vaccines must be approved by the…
To what standard should the FDA hold new drugs? The FDA has a number of choices. Drugs companies could be required to prove that the drugs they make: Do no harm. Are more effective than placebos Are more effective than existing drugs Are more cost-effective than existing drugs, or Are both more effective and more…
The Consumer’s Union used Medicare.gov to show that many people could save $3,500-$5,000 by switching to generics. Why don’t more people do so? One reason is the long delays for FDA approval of generics. The FDA’s Office of Generic Drugs is understaffed and thus generic drug approvals takes much longer than it should. Brand name…
Conventional wisdom holds that economists advocate for reducing regulation on most policy arenas. Regulation imposes costs and businesses and is often ineffective. Further, as technology and market conditions change, regulations which were originally welfare enhancing can now become archane. The public generally views the FDA’s pre-approval as a worthwhile endeavor. The goal of FDA pre-approval…
Before a drug can come to market, it must receive FDA approval. This involves 3 phases of testing with Phase I having 20-80 volunteers and Phase III often testing more than 1,000 people. Despite the FDA approval, patients can sue drug companies if they are injured by a drug. Patients can generally sue manufacturers under…