Page 46 - Prevention - USA (April 2020)
P. 46

H E A LTH





         The Doctor Is In


         Can You Trust



         That Product?                                        through an arduous approval


                                                              process (showing that they
         BY L AUREN STREICHER, M.D.
                                                              work and that their benefits
                                                              outweigh their risks) before
                                                              getting to market. The average
                                    ou grab a health          time it takes for a drug to hit
                                    product off the shelf—    the pharmacy is 12 years, and
                                    maybe it promises to      hundreds of millions of dollars
                             Yleakproof your bladder   are spent on research, devel-
                           or erase your wrinkles. And        opment, and trials. Note that
                           look, there’s an FDA logo right    the FDA does not actually test
                           on the product’s package! So       these drugs; it simply reviews
                           you feel hopeful that it might     the testing processes.
                           actually work.
                              Surprise: Many products         FDA CLEARED:
                           with an FDA logo haven’t           A Step Down
                           gone through any kind of           Three classes of devices require
                           testing process to make sure       FDA clearance, from no-risk
                           their claims are legitimate.       products needing no premarket
                           When you look more closely         review (such as dental floss) to
                           at that reassuring blue FDA        devices for medical use (like
                           logo, there’s a good chance        heart valves) that are poten-
                           you’ll see that it says FDA        tially high-risk and seek full
                           listed or FDA registered           FDA approval. Keep in mind
                           rather than FDA cleared            that some devices are eligible
                           or FDA approved. So what’s         for FDA clearance if they’re
                           the difference?                    similar to one that the FDA

         Dr. Streicher is                                     already deemed safe and more
         a clinical professor   FDA APPROVED:                 effective than a placebo, even if
         of obstetrics                                                                             ILLUSTRATION BY KATHRYN RATHKE.
         and gynecology    The Toughest Category              that happened years before.
         at Northwestern   Prescription drugs and             So an FDA-cleared product
         University’s      medical devices for specific       is likely safe, but it won’t
         Feinberg School
         of Medicine.      medical conditions have to go      necessarily work for everyone.

         44  PREVENTION.COM • AP R I L  2020
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