State Laws on Off-label Promotion May Force FDA’s Hand: Report
A push by states to relax off-label communications between the pharmaceutical marketers and physicians and insurers may force FDA’s hand at curbing such restrictions nationally. That is the premise behind a recent Pew Charitable Trust Stateline report reprinted in the Washington Post and entitled “Pressure mounts to lift FDA restrictions on off-label drugs.” Author Michael Ollove points to an Arizona law earlier this year to allow drugmakers to communicate directly with such professionals about alternative uses of approved prescription drugs. Advocates say they expect similar measures to be introduced in other state legislatures in the coming year, according to Ollove.
Many FDA watchers have predicted that FDA may tweak its communications policy with the arrival of commissioner Scott Gottlieb, who for years has favored looser restrictions on off-label promotion. Attorney James Beck (Reed Smith) said earlier this year that based on Gottlieb’s previous agency and non-agency statements, he doubts “that FDA’s absolutist ban on truthful industry speech about off-label uses will continue much longer in its current form.” Writing in an online blog post, Beck quotes from several Gottlieb presentations on the subject and says that defendants in cases involving off-label-use-related allegations should consider having their FDA experts review and, if appropriate, rely upon the current FDA commissioner’s positions, particularly to rebut contrary views offered by former FDA officials.
Stateline author Ollove drew comparisons to state actions on “right to try” bills that give terminally ill patients access to experimental medicines as an equal means to effect off-label communication changes. In fact, earlier this month at a Congressional hearing, Gottlieb announced changes to ease patient access to experimental therapies under its expanded access program. He also noted that agency officials have offered technical expertise on a right to try bill moving its way through Congress.
Additionally, Ollove acknowledged two bills in the House on relaxing off-label communications. One was filed by Rep. Morgan Griffith (R-VA) as an amended version of HR 1703, the Medical Product Communications Act. The measure would “clarify in statute that a new intended use may not be determined by reference to actual or constructive knowledge that a product is being used in a manner that varies from the approved labeling, non-public statements to that effect, or communications that fall within a scientific exchange safe harbor established by the legislation,” according to a background document.
The second bill is an amended version of HR 2026 offered by Rep. Brett Guthrie (R-KY) that would clarify how drug and medical device companies can share health care economic or scientific information with certain entities if it is based on competent and reliable scientific evidence and relates to an investigational use of a drug or device. “In order for information relating to an investigational use of an approved or cleared product to be provided under this statutory provision,” the background document says, “the study or studies the manufacturer anticipates could be sufficient to support the approval of the new use must have been conducted; the manufacturer must intend that a supplemental application will be submitted to FDA for such use; and information must include a conspicuous and prominent statement describing any material differences between the information provided and the FDA-approved product labeling.”
Both of the bills were reviewed during a July Capitol Hill hearing, but they have stalled ever since. Currently, they are listed without any additional actions or co-sponsors.
And then there are the critics who remain firmly opposed to such efforts. “There have literally been dozens and dozens of examples of off-label uses of drugs encouraged by pharmaceutical companies in reckless ways that have led to substantial patient morbidity and mortality,” Harvard’s Aaron Kesselheim is quoted in the Stateline report as saying. “If you take it as your premise that an objective approval by someone with no financial interest is necessary to protect patients, then marketing a drug for unapproved uses is the same as marketing an unapproved drug,” said Public Citizen’s Allison Zieve. To allow drugmakers to do so, she said, would undermine the whole system of FDA drug approval.