Quick Hits: The House of Representatives has passed “Right to Try” legislation which will allow patients with life-threatening illnesses to access experimental medications that are not approved by the FDA. The measure, which President Trump has said he will sign, has been considered a “lifeline for desperate patients” among some supporters. However, other medical and consumer groups have deemed the legislation “unnecessary” and “dangerous,” and some see it as potentially harmful to patients. Patients currently have 2 options to seek access to experimental medications: enrolling in clinical trials if they are eligible, or participating in the FDA’s “expanded access” program. Under this new measure, the FDA will basically be excluded from the “right to try” process, which will ease restrictions currently placed on drug manufacturers. Drug manufacturers would be required to report adverse events — safety problems, including premature deaths — only once a year. Under “expanded access,” adverse events must be reported within 15 days and within 7 days if the event is fatal or life-threatening. Posted May 22, 2018. Via The Washington Post.
Quick Hits: The FDA is advising parents to stop using over-the-counter teething products that contain the anesthetic benzocaine because the products are dangerous. Children — especially those under the age of 2 — can experience a rare but serious blood disorder known as methemoglobinemia while using the pain reliever, according to the agency. Methemoglobinemia is a condition that “elevates levels of methemoglobin in the blood” and can lead to death. The agency sent a letter urging manufacturers to discontinue the teething products immediately. If the companies fail to comply, the agency will initiate a regulatory action to pull those products from shelves. The agency is also requesting that manufacturers add new warnings that outline serious risks to all other benzocaine oral health products. Posted May 23, 2018. Via FDA.
Quick Hits: Tennessee has become the second state to legalize off-label drug promotion. Under the new legislation — which will go into effect on July 1 — companies will be able to market their products for off-label uses (conditions not approved by the FDA) as long as doctors are provided with truthful information. Tennessee has now joined Arizona, which adopted the law last year. This new measure is drawing some concern from experts. Michael Sinha, MD, JD, MPH, a Harvard Medical School professor, told STAT News, “Off-label marketing has a long history of endangering patients as manufacturers have used this strategy in the past to promote off-label uses that are unsafe and have weak evidence of efficacy, often with the goal of selling more product.” Posted May 10, 2018. Via STAT News.
