From his days adorned with vibrant curls of red hair to the bright white of his current years, esteemed Dr. Leslie Hendeles put forth a significant portion of his career urging the Food and Drug Administration (FDA) to reconsider the inclusion of a specific decongestant in cold medicines, Phenylephrine.
For half a century, his critiques, testimonies, and opposing views sought to expel what he perceived as an unproductive ingredient from one of the most sought-after cures during cold and flu seasons.
Delving into The Crux of the Matter
Among the labyrinthine rows of cold and flu remedies in the average pharmacy is an ingredient by the name of Phenylephrine, featured in a constellation of over 250 popular medicinal products, from the generic DayQuil to those under renowned brands like Tylenol and Theraflu. It reached a vital turning point when an advisory panel, spurred partially by Dr. Hendeles’ insistence, presented its conclusion; the decongestant, they proposed, was ineffective when swallowed through pill or liquid forms.
A response from consumers across the nation was instantaneous, rummaging through their medicine cabinets only to find the contentious ingredient listed in a gamut of their go-to products. Compounded with the announcement was a wave of uncertainty, with experts asserting that Phenylephrine, while ineffective orally, could still alleviate nasal congestion through sprays.
Resistance or Acceptance?
As with any significant change in an established industry, the shift away from Phenylephrine will not occur instantly. FDA’s gears will need to align to assess the panel’s proposition, gather public view, and provide a grace period for manufacturers. This slow process will allow brands sufficient time to amend their existing formulas rather than face the sudden elimination of their products from store shelves. However, the road ahead may not be devoid of obstructions, as corporations challenge the FDA’s actions in court or defend the ingredient’s effectiveness.
One notable advocate for Phenylephrine is Dr. Scott Gottlieb, a former FDA commissioner, who has long championed the ingredient’s effectiveness, albeit to a limited degree. His and other potential defenders’ counter-arguments may add a layer of complexity to any legislation seeking to ban the decongestant.
A Tangled Web of Regulations and Delays
The longevity of Phenylephrine in the market across an expanse of decades despite consistent inquiries and studies is a puzzle, ticking off regulatory norms from as far back as President Kennedy’s term, to the 1990s’ meth labs using cold remedies, extending to the current Covid-19 pandemic. The FDA, much like other federal agencies, functions under a number of antiquated rules, sometimes hindering progress.
Dr. Joshua Sharfstein, a former agency official and currently a vice dean at the Bloomberg School of Public Health at Johns Hopkins, stated, “There is no question that regulation of over-the-counter medications was broken for many years.” He further suggested that the FDA’s latest actions signify the beginning of a new chapter where the agency is liberating itself from existing constraints.
Dissecting the Phenylephrine Saga
The journey of inspecting Phenylephrine was, undeniably, a marathon. The drug, known for its potency in dilating eyes and soothing hemorrhoids, spent approximately six decades under scrutiny. Culminating with the FDA’s declaration in 1976, Phenylephrine stepped into a new realm, with the agency actively examining over-the-counter cold medicines as a whole.
Dr. Hendeles and his team of academic pharmacists at the University of Florida scrutinized the data used in the 1970s for the drug’s initial approval. Hence, the tale of the decongestant that eluded a full approval from the early 1990s is a testament to their dedication and relentless pursuit towards establishing the truth behind Phenylephrine’s claims.
