A Proposal to Import Drugs from Other Countries Creates an Unusual Alliance in the Senate

A Proposal to Import Drugs from Other Countries Creates an Unusual Alliance  in the Senate | Kaiser Health NewsSource: Kaiser Health News, by Victoria Knight

Harmony is not often found between two of the most boisterous senators on Capitol Hill, Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.).

But it was there at Tuesday’s Senate Health, Education, Labor and Pensions Committee markup of legislation to reauthorize the Food and Drug Administration’s user fee program, which is set to expire Sept. 30.

This user fee program, which was first authorized in 1992, allows the FDA to collect fees from companies that submit applications for drug approval. It was designed to speed the approval review process. And it requires reauthorization every five years.

Congress considers this bill a must-pass piece of legislation because it’s used to help fund the FDA, as well as revamp existing policies. As a result, it also functions as a vehicle for other proposals to reach the president’s desk — especially those that couldn’t get there on their own.

And that’s why, on Tuesday, Sanders took advantage of the must-pass moment to propose an amendment to the user fee bill that would allow for the importation of drugs from Canada and the United Kingdom, and, after two years, from other countries.

Prescription medications are often much less expensive in other countries, and surveys show that millions of Americans have bought drugs from overseas — even though doing so is technically illegal.

“We have talked about reimportation for a zillion years,” said a visibly heated Sanders. “This bill actually does it. It doesn’t wait for somebody in the bureaucracy to make it happen. It actually makes it happen.” He then went on for several minutes, his tone escalating, citing statistics about high drug prices, recounting anecdotes of people who traveled for drugs, and ending with outrage about pharmaceutical companies’ campaign contributions and the number of lobbyists the industry has.

“I always wanted to go to a Bernie rally, and now I feel like I’ve been there,” Paul joked after Sanders finished talking. He went on to offer his support for the Vermont senator’s amendment — a rare bipartisan alliance between senators who are on opposite ends of the political spectrum.

“This is a policy that sort of unites many on both sides of the aisle, the outrage over the high prices of medications,” added Paul. He said he didn’t support drug price controls in the U.S. but did support a worldwide competitive free market for drugs, which he believes would lower prices.

Even before Sanders offered his amendment, the user fee bill before the committee included a limited drug importation provision, Sec. 906. It would require the FDA to develop regulations for importing certain prescription drugs from Canada. But how this provision differs from a Trump-era regulation is unclear, said Rachel Sachs, a professor of law at Washington University in St. Louis and an expert on drug pricing.

“FDA has already made importation regulations that were finalized at the end of the Trump administration,” said Sachs. “We haven’t seen anyone try to get an approval” under that directive. She added that whether Sec. 906 is doing anything to improve the existing regulation is unclear.

Sanders’ proposed amendment would have gone further, Sachs explained.

It would have included insulin among the products that could be obtained from other countries. It also would have compelled pharmaceutical companies to comply with the regulation. It has been a concern in drug-pricing circles that even if importation were allowed, there would be resistance to it in other countries, because of how the practice could affect their domestic supply.

A robust discussion between Republican and Democratic senators ensued. Among the most notable moments: Sen. Mitt Romney (R-Utah) asked whether importing drugs from countries with price controls would translate into a form of price control in the U.S. Sen. Tim Kaine (D-Va.) said his father breaks the law by getting his glaucoma medication from Canada.

The committee’s chair, Sen. Patty Murray (D-Wash.), held the line against Sanders’ amendment. Although she agreed with some of its policies, she said, she wanted to stick to the importation framework already in the bill, rather than making changes that could jeopardize its passage. “Many of us want to do more,” she said, but the bill in its current form “is a huge step forward, and it has the Republican support we need to pass legislation.”

“To my knowledge, actually, this is the first time ever that a user fee reauthorization bill has included policy expanding importation of prescription drugs,” Murray said. “I believe it will set us up well to make further progress in the future.”

Sen. Richard Burr (R-N.C.), the committee’s ranking member, was adamant in his opposition to Sanders’ amendment, saying that it spelled doom for the legislation’s overall prospects. “Want to kill this bill? Do importation,” said Burr.

Sanders, though, staying true to his reputation, didn’t quiet down or give up the fight. Instead, he argued for an immediate vote. “This is a real debate. There were differences of opinions. It’s called democracy,” he said. “I would urge those who support what Sen. Paul and I are trying to do here to vote for it.”

In the end, though, committee members didn’t, opting to table the amendment, meaning it was set aside and not included in the legislation.

Later in the afternoon, the Senate panel reconvened after senators attended their weekly party policy lunches and passed the user fee bill out of the committee 13-9. The next step is consideration by the full Senate. A similar bill has already cleared the House.

Bill Would Eliminate Medicare Advocacy Services

The Senate Appropriations Committee recently approved the FY17 Labor, HHS, Education Appropriations bill, which would eliminate funding for the State Health Insurance Assistance Program (SHIP). It’s called the Health Insurance Counseling and Advocacy Program (HICAP) in California. It is the only program that provides free, unbiased, one-on-one Medicare coverage and benefit counseling for beneficiaries, family members, and caregivers. According to California Health Advocates, “This dangerous bill aims to eliminate this important, effective program that helps millions of beneficiaries nationwide better understand and navigate the increasingly complex Medicare program.”

Bill Aims to Protect Consumers Amid Health Care Mergers

This week, the Senate Health Committee will hear S.B. 932 (Hernandez). The bill would require state regulators to scrutinize proposed health industry consolidations to ensure that they are in the interest of consumers. The public would have opportunities to offer comment and feedback on the deals. The bill would prevent hospitals from making anti-competitive demands when negotiating with health plans and insurers. Hospitals, especially those with a large market share, would not be allowed to insist on contract provisions that result in them being the only option for care.

This bill has been introduced in the midst of a wave of pending health care mergers in California. Two of four major health insurance mergers have been finalized: Blue Shield of California acquired Care1st last year, and Centene’s proposal to acquire Health Net was approved with conditions by state regulators last month. Two other health insurance mergers are still pending, Aetna-Humana and Anthem-Cigna. Other hospital and health mergers have also taken place, including the Daughters of Charity Health System purchase by an investment firm in 2015.

Anthony Wright, executive director of Health Access California said, “Health industry mergers have led to price increases, less choice, and greater consolidation. Companies…almost always say that the merger will lead to efficiencies and savings, but they rarely…pass those [savings] to consumers, if [the savings] ever actually materialize. Companies that want to merge need to show that the merger causes no harm to consumers, and that consumers will actually benefit. Some of these health mergers are required to face public hearings and scrutiny while others fly under the radar. It’s time to set a clear standard of…oversight for all these deals that have such a profound impact on the health system.”

Group Calls on Senate to Prevent Secret Pharma Money

Section 3041 of the 21st Century Cures Act would remove reporting requirements over pharmaceutical industry payments to doctors and associations that take place in the context of Continuing Medical Education (CME). The UNITE HERE union sent letters to the Senate Committee on Health opposing the legislation. They say it would allow millions of dollars’ worth of pharmacy industry gifts to doctors’ conferences to happen behind closed doors. The bill just passed the House and is expected to be introduced in the Senate soon.

Aside from healthcare providers and pharmaceutical reps, hospitality workers are among the only people who witness the pharmaceutical industry’s presence at CME events. If Section 3041 becomes law, the rest of the public will never see what UNITE HERE members see. In the past two months, UNITE HERE has collected over 9,000 signatures on a petition to the Accreditation Council for Continuing Medical Education (ACCME) to eliminate pharmaceutical money from CME.

UNITE HERE says it is concerned about ballooning costs for its members’ healthcare plans. Prescription drugs, devices, and biologicals are a major factor in rising healthcare costs and the union is concerned doctors may be unduly influenced by contributions from the pharmaceutical industry to prescribe more expensive drugs when more affordable, generic alternatives are available. The letter was also signed by the director and the program manager of PharmedOut, a Georgetown University Medical Center Project that promotes rational prescribing. UNITE HERE represents 270,000 workers in North America who work in the hotel, gaming, food service, manufacturing, textile, distribution, laundry, transportation, and airport industries. For more information, visit NoMoreDrugMoney.org/Senate.

Senate Bill Would Expand Access to Pharmacies

The National Community Pharmacists Association (NCPA) strongly endorses The Ensuring Seniors Access to Local Pharmacies Act, S. 1190. The legislation would expand the number of pharmacies that can offer discounted copays for Medicare Part D prescription drugs. It was introduced by Senators Shelly Moore Capito (R-W.Va.), Joe Manchin (D-W.Va.), Tom Cotton (R-Ark.) and Sherrod Brown (D-Ohio).

Medicare beneficiaries in medically under-served areas would be able to access lower copays at any pharmacy that agrees to accept a drug plan’s preferred pharmacy terms and conditions. S. 1190 is a companion bill to H.R. 793, The Ensuring Seniors Access to Local Pharmacies Act, which has been introduced by Reps. Morgan Griffin (R-Va.) and Peter Welch (D-Vt.). NCPA CEO Douglas Hoey, RPh, MBA said, “Medicare beneficiaries should not be confronted with the Hobson’s choice of continuing to patronize their pharmacy at a higher cost or making a long trip to another pharmacy.”

The bill has been endorsed by the Alliance for Retired Americans, the Center for Medicare Advocacy, Families USA, Justice in Aging, the Medicare Rights Center, the National Consumers League, the National Rural Health Association, and the U.S. Pain Foundation. “Today many Medicare beneficiaries are effectively told by drug plan middlemen which pharmacy to use based on exclusionary arrangements among the pharmacy benefit manager (PBM) middlemen and, in most instances, large publicly traded chain pharmacies,” Hoey added. According to a recent Medicare study, in urban areas 54% of preferred pharmacy drug plans failed to meet the government’s threshold for reasonable access to pharmacies. In rural America the closest preferred pharmacy can be 20 miles away or more.

Last Updated 06/29/2022

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