Health and Human Services Secretary Alex Azar has been summoned to Capitol Hill to explain how President Donald Trump plans to lower the prices of prescription drugs in the U.S. and what role the White House expects Congress to play in that effort.
Azar is expected to testify about Trump's drug prices blueprint, which he unveiled May 11, at a June 12 hearing convened by the Senate Health, Education, Labor and Pensions, or HELP, Committee.
A key part of the strategy calls for merging the separate ways the U.S. federal government pays for medicines under Medicare — an idea panned by the drug industry.
Trump wants to move some or all of the drugs covered by the Medicare Part B program — medicines administered in the doctor's office or outpatient healthcare clinic — to the Medicare Part D prescription drug program.
But Stephen Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, said that approach could have unintended consequences of upsetting the competitive dynamic of the programs.
"We're not here to defend the status quo," he said during a May 23 forum in Washington hosted by his group and The Atlantic. "We think the system is not always structured in the best interests of patients and we think change is necessary. But the real question is what's the right kind of change?"
Azar, however, made it clear during a March 16 address at the American Enterprise Institute that the merger of the two programs was "going to happen."
"So it would be most productive if the pharmaceutical industry came to us with a plan for these changes," the health chief said.
Trump, however, backed away from his promise to seek authority for Medicare to negotiate directly with drugmakers on prices.
FDA plans June internet summit
U.S. Food and Drug Administration Commissioner Scott Gottlieb has invited senior executives from major internet search engines, social media platforms, domain name registries and online marketplaces to join him and academic researchers and leaders from government entities and advocacy groups on June 27 for a one-day summit to discuss ways to collaboratively take stronger action to combat the U.S. opioid crisis by reducing the availability of the drugs sold illicitly online.
In April, Gottlieb told social media sites, such as Twitter Inc. and Facebook Inc., that they must do more to halt ads and illicit offers on their platforms for fentanyl and other opioids.
Gottlieb invited the various stakeholders at the summit, which is being held at the FDA's headquarters in Silver Spring, Md., to briefly present current approaches their organizations have taken to address the opioid epidemic.
Gottlieb first revealed his plans to hold the meeting during an April 4 speech at the National Rx Drug Abuse & Heroin Summit in Atlanta.
In advance of the internet summit, which will be webcast, the FDA commissioner asked his invited guests to provide his agency with any steps their organizations have implemented to prevent opioids from being offered online.
The FDA chief plans to ask the internet organizations to commit to the agency's pledge to reduce the availability of illicit opioids online, according to the invitation.
On May 28, Gottlieb also said the FDA was going to be stepping up its enforcement activities in the coming weeks as part of a sustained campaign.
Senators introduce, advance more opioid bills
The Senate Judiciary Committee last week advanced five bills aimed at addressing the U.S. opioid crisis, while members of the chamber's Finance Committee introduced another 22 pieces of related legislation.
The committees' bills could be added to a legislative package adopted in April by the Senate HELP panel, which is expected to be considered sometime this summer by the full chamber.
"The impact that the opioid crisis has caused cannot be solved with only one change, one law or one committee," said Sen. Chuck Grassley, R-Iowa, the Judiciary panel's chairman.
Sens. Orrin Hatch, R-Utah, and Ron Wyden, D-Ore., chairman and ranking member, respectively, of the Senate Finance Committee — which oversees more than 50% of the federal budget and has jurisdiction over large portions of the U.S. healthcare system, including Medicare, Medicaid and the Children's Health Insurance Program — have yet to firm up a date to consider the 22 newly introduced bills, but said they were committed to convening a markup session in the coming weeks and were seeking to move the measures under regular order to the chamber floor.
The two senators in February requested feedback from various stakeholders on what payment incentives for Medicare and Medicaid — the government's insurance programs for the elderly and the poor, respectively — could be used to promote evidence-based care for beneficiaries with chronic pain that would minimize the risk of developing opioid addiction and other substance-use disorders and if there were barriers blocking the use of non-pharmaceutical therapies.
The lawmakers held a hearing in April to gain insight from officials from the Department of Health and Human Services, or HHS, and the Centers for Medicare and Medicaid Services on those matters.
The five bills from the Judiciary Committee were each reported favorably on May 24 to the full Senate by a voice vote.
Earlier this month, the House Energy and Commerce Committee cleared 57 opioid-related bills over two sessions on May 9 and May 17 — sending the measures to the chamber's floor for consideration.
Rep. Greg Walden, R-Ore., chairman of the committee, said he received a commitment from Majority Leader Kevin McCarthy, R-Calif., that the House would take up those in June.
The House Ways and Means Committee also has been working on separate bills.
Senator probes docs' opioid courses
Meanwhile, Sen. Ed Markey, D-Mass., last week called on HHS' Azar and several independent accreditation agencies to explain their roles in ensuring that courses intended to educate licensed healthcare professionals about opioids are not unduly influenced by makers of those drugs and reflect current scientific and medical information.
Markey noted that a recent report found that many prescribers' courses do not conform to the guidelines laid out by the Centers for Disease Control and Prevention and do not reflect the most recent science on the treatment of chronic pain or the inherently addictive nature of opioids.
"I am concerned that the industry's profit motives may be improperly influencing the education that prescribers receive and endangering countless American lives," Sen. Markey wrote in May 24 letters to Azar and the American Association of Nurse Practitioners, the Commission for Continuing Education Provider Recognition, the Accreditation Review Commission on Education for the Physician Assistant, the American Nurses Association and the Accreditation Council for Continuing Medical Education.
Markey noted that over-prescribing is one of the leading causes of the opioid epidemic.
Senate panel advances biodefense bill
The Senate HELP Committee last week advanced legislation aimed at funding the U.S. biodefense enterprise to ensure the nation is prepared to meet any potential chemical, biological, radiological or nuclear threats or natural disasters, like hurricanes or a pandemic.
The measure, which now goes to the full Senate for consideration, would reauthorize the 2006 Pandemic and All-Hazards Preparedness Act, which created the Biomedical Advanced Research and Development Authority, or BARDA — the government agency that supports the transition of medical countermeasure candidates, like vaccines, drugs and diagnostic tools, from the early stages of development into advanced development towards FDA approval and potential procurement.
The law, which was last renewed for five years in 2013, expires at the end of September.
In addition to renewing BARDA through 2023, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 would reauthorize for another five years the BioShield Special Reserve Fund, which was created by Congress in 2004 for procuring medical countermeasures for stockpiling.
"The recent resurgence of Ebola in the Congo should serve as a stark reminder that the threats we are working to address in this bill aren't hypothetical," Sen. Patty Murray, D-Wash., the ranking member on the HELP Committee, said at the May 23 markup session.
The panel had examined the legislation during a series of hearings held earlier this year.
