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What We're Reading: Off-Label Use of Generics; Flu Deaths; Congenital Syphilis on the Rise
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Senators Orrin Hatch, R-Utah, and Michael Bennet, D-Colorado, have introduced a new bill that would allow the FDA to include off-label uses on certain generic drug labels; in the 2017-2018 flu season, influenza killed 80,000 Americans, easily surpassing the previous record of 56,000 deaths for a regular flu season; in the last 4 years, the number of babies born with syphilis has more than doubled, reaching a 20-year high.
New Bill Would Put Off-Label Uses on Generic Labels
Senators Orrin Hatch, R-Utah, and Michael Bennet, D-Colorado, have introduced a new bill that would allow the FDA to include off-label uses on certain generic drug labels. Currently, only branded drug makers can submit a label change to the FDA to market a drug for a new use, which means generic labels don’t have the most up-to-date information, explained STAT. The bill would allow the FDA to order a generic maker to change a drug label after reviewing existing data on off-label uses for generics that do not have branded competitors. Since additional data on potential uses for a drug can be discovered after the drug hits the market, outdated labels are a big problem, according to Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA.
Flu Deaths and Hospitalizations Broke Records Last Flu Season
In the 2017-2018 flu season, influenza killed 80,000 Americans, easily surpassing the previous record of 56,000 deaths for a regular flu season. According to The Washington Post, vaccination coverage was flat last year, despite warnings of how dreadful the season was and how long it lasted. In fact, coverage of children younger than age 5 actually declined. Last year’s vaccine was about 40% effective, according to a final estimate, which may have caused some people to not get it. The CDC is recommending everyone 6 months and older get the vaccine before the end of October.
Syphilis Rate Among Babies Reaches 20-Year High
Pregnant mothers can pass syphilis on to their unborn babies, which can cause miscarriages and stillbirths, and babies who are born can suffer serious health problems. In the last 4 years, the number of babies born with syphilis more than doubled, reaching a 20-year high, according to The New York Times. While congenital syphilis can be treated, the damage—such as deformities, seizures, and anemia—can last a lifetime. Louisiana, Nevada, California, Texas, and Florida have the highest rates of congenital disease.
