FDA changes drug import stance, leaving pharma industry aghast

The US regulator has said it wants to look into ways to import medicines as a means to overcome high prices, though critics fear the plan could expose citizens to substandard or counterfeit drugs.

Imports have been perennially held up as a way to tackle high prices, but have been generally resisted by the FDA to date – in fact four prior FDA Commissioners (Robert Califf, Margaret Hamburg, Andrew von Eschenbach and Mark McClellan) sent an open letter to Congress last year saying it could “harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation's medical products.”

In the latter, they go onto say that “global experience confirms that illicit, ineffective, or adulterated products are readily available on the open market and represent one of the most lucrative avenues of organised crime.”

Now, Commissioner Scott Gottlieb (pictured) seems set to buck that trend by setting up a working group to look into importing drugs approved overseas but not yet in the US, albeit in selected circumstances. Specifically, where there is just one supplier of a drug in the US market who is using that position to charge over the odds.

The request to do so comes down from Health and Human Services Secretary Alex Azar, who said “importation may well fit that bill in some instances.”

In a statement, Gottlieb said “any policy that involves the importation of drugs would be temporary until adequate competition enters these categories,” adding: “any resulting policy would also be narrowly tailored in order not to create the same risks of counterfeits or other unsafe drugs getting into the US supply chain.”

“Our ultimate goal is to seek multiple FDA-approved and marketed versions of each medically important drug for which there are no blocking patents or other exclusivities.”

There are concerns however that by opening the importation door a crack, it could encourage the efforts of those seeking to allow importation on a wider scale

The move has been rebuked by pharma industry groups. PhRMA – representing the research-based sector, issued a statement saying, “importation of non-FDA approved medicines is not the solution.” It would “circumvent the robust safety requirements we have in US, posing a serious public health risk and jeopardising our secure medicine system,” it said.

Meanwhile, the Association of Accessible Medicines, which represents the generic industry, said the most important goal of the new HHS task force should be to address why there are sole source off-patent drugs in the first place.

“Importation of prescription drugs manufactured overseas will not solve the underlying under-reimbursement issues that Secretary Azar identified,” it asserted.

And the biotechnology industry group BIO added its own criticism, saying it was a “dangerous approach” that would provide “illusory savings, as the government itself has repeatedly acknowledged.”

The HHS move comes in the midst of a clampdown on drug pricing by President Donald Trump, who fired a broadside across the bows of the pharma industry earlier this year when he accused companies of “making an absolute fortune at the expense of American consumers.”

In May, the White House published a blueprint  that included a raft of proposed measures, including rebate-sharing in Medicare drug plans, promoting generics and biosimilars of biologic drugs and requiring drug manufacturers to publish list prices for drugs in television advertisements.

Merck, Novartis and Pfizer have all said they would limit price increases this year while they wait for the implementation plan for the blueprint is published.

The moves haven’t impressed lobby group Patients for Affordable Drugs, which said in response: “Let’s keep reality in focus: Drug companies don’t get credit for keeping prices high. Novartis and Pfizer temporarily postponed regularly scheduled price gouging — they didn’t reduce prices or increase patient access.”

“The bar for giving drug corporations credit for good behaviour cannot be this low,” it continues.

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