The oversight committee probing FDA’s actions on decongestants.
The House oversight committee has informed Axios that Republican lawmakers will investigate why the FDA ruled out a common decongestant ingredient found commonly in cough remedies.
Why it matters ?
It is the newest of aggressive investigative agenda by house republicans looking at why the FDA did not act soon enough against OTC’s for various other cough and cold drugs which sold nearly $1.8 billion worth of sale last year.
Driving the news
Today, Rep. Lisa McClain, R-Mich., chairman of the House Oversight subcommittee on health care and financial services, will send a letter asking for a briefing with commissioner Robert Califf of the Food and Drug Administration (“FDA”).
• The FDA basis for so many years rested on outdated and inadequate evidence concerning phenylephrines’ usage within such nasal drops as decongestants.
• Americans, therefore, looking for OTC medications should not be anxious as to whether they spent their hard earned
Catch up quick
A September FDA advisory panel determined that phenylephrine, which is in over-the-counter medications such as Sudafed PE and some versions of NyQuil, isn’t effective when taken by mouth.
For more than a decade, there have been concerns about its efficacy, with the FDA reviewing it approximately twenty years ago. Agency scientists noted that they are subsequent large scale studies that have shown out orality based formulations are ineffective since that time.
In October, CVS Health decided to take up and voluntarily remove common decongestants containing only active ingredient phenlypiraminate sold over-the-counter from their shelves.
Since then,
Doctors and other health specialists have questioned the effectiveness of a high percentage of OTC cold medication, according to an NRP report.
What we're watching: FDA is anticipated to determine if it will take these products with oral phenylephrine in a recall.