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OMB concludes drug import rule review; NIH chief vows sexual harassment reform

The White House Office of Management and Budget has concluded its review of a proposed rule that would permit foreign imports of prescription drugs into the U.S., according to industry sources.

The end of the OMB's review may mean the proposal could be unveiled soon — an action President Donald Trump has repeatedly vowed since October was imminent.

SNL ImageHHS Secretary Alex Azar and President Donald Trump
Source: AP Photo

The OMB was scheduled to hold meetings in January with The Partnership for Safe Medicines and the Pharmaceutical Research and Manufacturers of America.

But both groups confirmed to S&P Global Market Intelligence that OMB canceled those January sessions and completed its review before meeting with the industry representatives to obtain feedback.

"We hope that this is not politically motivated, given the timing of such a move, particularly in light of the grave consequences of allowing drug importation," said Shabbir Safdar, executive director at The Partnership for Safe Medicines, whose members include PhRMA.

OMB and the U.S. Department of Health and Human Services did not respond to requests for comment.

In late July, HHS outlined two pathways as potential courses of action for importing prescription medicines into the U.S. as a way to lower Americans' drug costs.

The pathways involve pilot projects run by states, wholesalers and pharmacists for importing medicines from Canada and a complicated process that would let manufacturers sell products intended for foreign markets in the U.S.

The task of implementing and overseeing the importation program would fall on the U.S. Food and Drug Administration, which will soon have a new commissioner, Stephen Hahn, who was confirmed by the U.S. Senate on Dec. 12.

Hahn declined to tell senators in November if he backs the Trump administration's importation plan.

The drug industry, Canada and others, including most Republicans on Capitol Hill, have objected to importing prescription medicines from foreign nations into the U.S.

"Both U.S. and Canadian stakeholders have provided clear and compelling arguments as to why this is a bad and unworkable idea," Safdar told S&P Global Market Intelligence. "Even as the administration weighs its next move, the process itself should not be driven by anything but the health and safety of the American people."

HHS Secretary Alex Azar had previously called drug importation a "gimmick," but later said the administration would find a safe way to make it work.

Florida submitted a plan to HHS in late August. Colorado said it was working on its plan. Both states have adopted legislation to permit foreign importation of prescription medicines. Vermont and Maine have done the same.

The Trump administration has been struggling to fulfill its promises to lower U.S. drug prices — first getting knocked back by a federal court in July on a rule to require drugmakers to disclose the list prices of their products in television commercials, and days later, abandoning a proposal to ban rebates paid by biopharmaceutical manufacturers under secret deals to middlemen.

SNL Image

Ways and Means Committee Chairman Richard Neal

Source: AP Photo

Last week, Democrats scored a major victory when the House adopted Speaker Nancy Pelosi's drug pricing package, which would permit the government to negotiate the costs of medicines on behalf of Medicare and the commercial insurance market.

Ways and Means surprise

A plan to get legislation adopted by the end of the year to prevent Americans from being hit with surprise medical bills was thrown into jeopardy last week after the bipartisan leaders of the Ways and Means Committee unveiled their own rival proposal.

Earlier in the week, Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander, R-Tenn., and the leaders of the House Energy and Commerce Committee, Reps. Frank Pallone, D-N.J., and Greg Walden, R-Ore., said they reached a deal after months of wrangling mostly over whether to use a benchmark approach or an arbitration process for resolving disputes over payments for surprise medical bills.

They settled on using an arbitration appeal process when providers dispute the benchmark payment.

The Ways and Means committee leaders said their legislation would use a "robust, impartial and structured process to settle payment" when the parties cannot come to an agreement on their own.

SNL ImageNIH Director Francis Collins
Source: National Institutes of Health

NIH chief vows sexual harassment reform

Also last week, Francis Collins, director of the U.S. National Institutes of Health, said he was supportive of new recommendations to end sexual harassment in science but noted his agency would need new and modified funding mechanisms to carry them out.

At a Capitol Hill hearing in April, Collins acknowledged the NIH and the U.S. scientific community overall have been confronting complaints about sexual harassment.

In late February, the NIH chief and other agency leaders apologized for taking "so long to acknowledge and address the climate and culture" of sexual harassment that has "caused harm" to some scientists' careers.