Trending News Today: Exodus of FDA Drug Reviewers to Manufacturers Raises Concerns
Top news of the day from across the health care landscape.
Following pressure from food companies who state that current regulations are outdate, the FDA has taken the first step towards redefining the definition of healthy. According to The Washington Post, government regulators are gathering the opinions of consumers, companies, and other members of the public on the how term healthy should be used on food packaging. The current definition of healthy was defined in 1994, with the primary focus on low-fat content, as sugar was not a widespread health care concern at the time. Under the definition today, food makers can only claim their products to be healthy if it meets the criteria for being low in fat, saturated fat, sodium, and cholesterol, while also having a certain amount of nutrients, such as calcium or vitamin C. While the FDA deliberates on how to redefine the rule they will exercise discretion in enforcing the current one, reported the Post. Although this process will take several years to complete, it is a major step in the right direction for changing the ideas about health.
The latest breakthrough in science occurred under the radar some 5 months ago, after a Jordanian couple conceived and gave birth to a baby with more than 2 genetic parents, reported The Washington Post. According to experts, the baby actually has more like 2.001 parents, and this newborn represents the first successful birth in a new wave of “3-parent” techniques. This new technique involves the transfer of mitochondrial DNA (mtDNA), which replaces the mother’s faulty mitochondria with donor mitochondria in the newly conceived embryonic cells. This allows for a healthy baby to be produced while still preserving a vast majority of the mother’s DNA. In this particular procedure, however, the parents were devout Muslims, and did not want to use a technique where embryos were destroyed. So instead, a technique that involved cutting and pasting before fertilization took place was used. Currently, the United Kingdom has embraced research on the genetic engineering of embryos, with one 3-parent technique already approved, while the United States has remained at a standstill. Researchers will describe their methods in greater detail at the American Society for Reproductive Medicine’s Scientific Congress in October.
More than one-quarter of individuals who served on the FDA from 2001 through 2010 have left the agency, and now work or consult for pharmaceutical companies, reported Kaiser Health News. In a new published study, researchers wanted to better understand the so-called revolving door between the FDA and the pharmaceutical industry. Although there are anecdotal cases of major players at the FDA who have left to go and work for the industry, researchers were unsure how frequently this happened. For the study, researchers tracked 55 FDA reviewers in the hematology-oncology field from 2001 to 2010, and found that of the 26 reviewers who left the FDA during this period, 15 (57%) later worked or consulted for the biopharmaceutical industry. Although leaving the FDA to work for the industry is not inherently bad, it does raise some questions, according to Kaiser. Although the study authors stated that FDA reviewers have a lot of power over the approvals, Dr. Joshua Sharfstein, the FDA’s principal deputy commissioner until 2011, disagreed. Sharfstein stated that within the review process, there are endless checks and balances, and it is not up to one person by-and-large. “Key regulatory decisions are looked at from many different angels,” Sharfstein said in the report. “I think it would be very difficult for an individual to do something inappropriate and not have that caught.”