By Sarah Ellison and Ryan MauePosted May 03, 2017 04:18:49Drug companies will likely have to make the same changes to their business models as other companies if the FDA rules against making antibiotics to kill people with a certain amount of antibiotics, according to a letter sent to drugmakers today.
The FDA has issued its rules to the drug industry for the first time in more than a decade, and some experts expect it to make significant changes to the way the industry sells antibiotics.
In a letter to drug makers, the FDA has also called for drug companies to change their business model by removing their “substantially equivalent” generic equivalents, as well as “any other marketing claims that could be construed as advertising.”
The letter, signed by acting FDA commissioner Maryann King, notes that “there is considerable evidence that some generic versions of some antibiotic are significantly more efficacious than comparable brand-name versions, particularly for certain indications, and that there is substantial uncertainty as to whether the efficacy of these generic versions can be attributed to their generics equivalents.”
The FDA says the FDA is working to develop a strategy to “implement a new approach to assessing and mitigating adverse events,” including the need for drugmakers to “prefer generic formulations.”
“This will require a shift in the way companies and health care providers use their own products,” the letter reads.
King said that in order to do so, she will “be meeting with the pharmaceutical industry over the next few months and making recommendations for how we can achieve this goal.”
The letter comes amid increasing concerns over the FDA decision to phase out generic versions and a growing backlash against the agency’s actions.
On Tuesday, the American Medical Association and other health care organizations filed a federal lawsuit challenging the FDA rule, saying the FDA failed to adequately consider alternatives to the brand-generic versions of antibiotics.