House reduces FDA authority over tobacco products, LDTs
The bill is specifically for fiscal year 2017. Many health professionals are concerned about how this will affect the overall health industry as it strives to reduce people’s use of tobacco and related products.
The American Cancer Society Cancer Action Network (ACS CAN) released a statement about the House passing this bill.
“The appropriations language passed today by the committee would significantly limit the FDA’s ability to protect youth from cigars, e-cigarettes and other unregulated tobacco products,” according to the statement. “An adopted provision in the bill would require the FDA to exempt many cigars, including some cheap and some flavored cigars often popular with youth, from oversight -- and could also block FDA regulation of a significant number of other increasingly popular tobacco products.”
Many people believe that the passage of this amendment serves political and financial connections that many U.S. leaders have with the cigar and e-cigarette industry, as it benefits business instead of people.
“Additionally, an amendment passed by the committee clearly benefits the cigar and e-cigarette industries at the expense of the nation’s public health and would undermine the 2009 law giving the FDA authority over all tobacco products,” according to the statement. “The loophole to change the 'grandfather date' would allow cigars, e-cigarettes and other tobacco products to escape a critical first-step review by the FDA and make it easier for new products to stay on the market before it is determined whether they attract youth or otherwise harm public health.”
In addition, LDTs are important diagnostic tests that many health professionals rely on to benefit their patients. It is crucial that LDTs are effective, which the FDA is meant to guarantee.
“As cancer patients and their doctors become more reliant on diagnostic tests, including LDTs, to identify the best treatment options, it is critical that the tests produce accurate and meaningful results, and current oversight of LDTs falls short of ensuring these tests live up to patient expectations,” according to the statement. “Further, LDTs are not required to report adverse events impacting patient health, which is why we firmly believe that the FDA is the most appropriate agency to verify the accuracy of these diagnostic tests.”