Andrew Siddons

Senate panel approves Trump's FDA nominee
Senators ask questions about the FDA's plans for regulating e-cigarettes

A Senate panel approved President Donald Trump’s nominee to lead the Food and Drug Administration amid questions from both parties about the agency’s plans for regulating flavored e-cigarettes.

The Health, Education, Labor and Pensions Committee voted 18-5 to advance to the Senate floor the nomination of medical executive and doctor Stephen Hahn.

FDA nominee to face questions on issues from vaping to salmon
It might be hard for Stephen Hahn to win over Democrats because of a pending White House vaping decision

When President Donald Trump’s nominee to lead the Food and Drug Administration appears for the first time before a Senate panel on Wednesday, he’ll likely face tough questions about some policy issues that he may not have thought much about previously.

While the nominee, Stephen Hahn, is a highly regarded cancer doctor who has helped lead a research hospital with a budget nearly the size of the FDA’s, the confirmation hearing will be a reminder of the breadth of the agency’s work.

Teens like vaping mint and mango Juul flavors over menthol and tobacco, study finds
The study comes amid speculation that the Trump administration may not include menthol in the flavored e-cigarette ban

A new National Institutes of Health-funded study published Tuesday said that menthol flavoring is one of the least popular e-cigarette flavors among teenagers, amid speculation that the Trump administration may not include menthol in the flavored e-cigarette ban it proposed in September.

That proposal cleared the White House Office of Management and Budget on Monday afternoon, which is the last step before public release.

Trump to nominate Texas cancer hospital leader to head FDA
Stephen Hahn is currently the chief medical executive at the MD Anderson Cancer Center in Houston

President Donald Trump on Friday announced he intends to nominate Stephen Hahn, a doctor and executive at one of the country’s leading cancer treatment hospitals, to be the next Food and Drug Administration commissioner.

Hahn is currently the chief medical executive at the MD Anderson Cancer Center in Houston. He is trained as a radiation oncologist, a field that uses radiation to kill cancer cells and tumors or slow their growth.

House Dems move forward with drug pricing bill
Committee approved a new plan that would limit drug prices — a top priority for the party

A House committee on Thursday approved a Democratic bill designed to limit drug prices, a top priority for the party, as another panel’s debate on the measure was poised to last for hours.

House leaders produced the 141-page bill after months of deliberations among various party factions, as progressives urged their colleagues to be bold despite GOP criticisms that the measure could hamper research into future cures. The bill, numbered HR 3, includes requirements for the Department of Health and Human Services to negotiate Medicare prices for the most expensive drugs, with commercial health plans also having the option of adopting those prices.

Trump aide calls drug price deal possible if impeachment fades
The aide said Democrats were making it harder to achieve the goal while being “distracted” by impeachment

President Donald Trump’s top domestic policy adviser on Monday predicted that the White House could strike a deal with House Democrats on drug prices — if the impeachment inquiry into the president ultimately doesn’t go anywhere.

Domestic Policy Council Director Joe Grogan said House Democrats deserve credit for proposing a drug price bill, which he called ambitious. He said he met last week with Speaker Nancy Pelosi’s health care adviser, Wendell Primus, as well as House committee staff, and the two sides had a “great” conversation about the legislation.

NIH could do more to address foreign threats, reports say
Reports stem from congressional fears that NIH-backed researchers could share taxpayer-funded research with foreign governments

The National Institutes of Health should do more to ensure that investigators and grant reviewers aren’t susceptible to foreign influence, according to a trio of reports from the Health and Human Services inspector general released Friday.

The inspector general recommended that the NIH enhance its vetting processes for the independent researchers who review grant applications. The agency could also do more to ensure that research institutions comply with requirements to ensure that investigators disclose all of their funding sources.

Pelosi says key component of drug pricing bill not open to negotiations
Pelosi rejects idea of negotiating bill that doesn’t allow the government to negotiate prices

House Democrats on Thursday released the outline of a long-awaited drug price proposal, taking a step toward fulfilling one of the party’s signature campaign promises: requiring Medicare to negotiate drug prices.

The bill would allow commercial insurers to benefit from the Medicare-negotiated price as well, and base Medicare’s highest-acceptable price on the lower prices other wealthy countries pay.

Bipartisan group urges FDA to go beyond vaping flavor ban
Senators call for more action to curb e-cigarettes

Senators from both parties emphasized to the Food and Drug Administration on Thursday that more should be done to curb youth vaping beyond the Trump administration’s decision a day earlier to ban e-cigarette flavors.

Acting FDA Commissioner Ned Sharpless briefed the senators in a morning meeting that the organizer, Minority Whip Richard J. Durbin, D-Illinois, described in positive terms. Last week, Durbin called on Sharpless to resign if the FDA did not restrict flavored e-cigarette sales, but Durbin said Thursday that Sharpless “responded to my letter in a positive way and I want to give him a chance to show that he’s serious.”

Trump orders end to flavored e-cigarette sales amid vaping-linked illnesses
Flavored e-cigarette makers will need to apply to the FDA for sales authorization

The Trump administration on Wednesday said it planned to halt the sales of flavored e-cigarettes amid a national outbreak of lung illnesses that may be linked to vaping devices.

Health and Human Services Secretary Alex Azar said the Food and Drug Administration will issue a new policy within several weeks that will require all flavored e-cigarettes to come off the market.

House drug price negotiation plan could apply beyond Medicare
Draft plan would have government set prices based on those in other wealthy countries

A comprehensive drug price bill being developed by House Democrats would give private insurers the benefit of government-negotiated prices, according to a summary of the measure obtained by CQ Roll Call.

Under the Democrats’ draft plan, the government would set prices based on what is paid in other wealthy countries, according to the summary. That is similar to how a proposal by the Trump administration would work.

Shootings add to pressure on gun violence research funding push
House-passed fiscal 2020 Labor-HHS-Education spending bill would provide $25 million on gun violence research

Lawmakers under pressure to address mass shootings could provide millions for research on gun violence, which would help fill a knowledge gap about policies that are most effective at reducing injuries and death, as Congress attempts to fund the government by Oct. 1.

House Democrats have proposed $50 million to study gun violence, and academics say the government funding could ensure that the data collection infrastructure is adequate to support a broad research enterprise.

NIH needs $1.3 billion for building repairs, report says
While more funding goes to research, aging facilities found in ‘deteriorating condition’

The National Institutes of Health needs a “substantial infusion of funding” to address the “deteriorating condition” of many of its facilities, according to a congressionally mandated report.

The report, released Monday by the National Academies of Sciences, Engineering and Medicine, recommends that Congress provide $1.3 billion in new funding over several years in order to address buildings and facilities at the NIH’s campus in Bethesda, Maryland.

New FDA cigarette labels include realistic images of smoking-related health problems
The long-delayed warnings, now subject to public comment, would update textual statements already on cigarette packs

The Food and Drug Administration on Thursday proposed long-delayed graphic health warnings for cigarette packages, taking a step toward fulfilling a requirement of a decade-old smoking prevention law.

The new warning label proposal will now be subject to a public comment period, and is under a court-ordered deadline to be finalized by March 15, 2020.

Gun research funding push faces challenge in Senate even after shootings
House-passed bill would be first time in decades Congress allocated funding specifically for gun violence research

Democrats in Congress are amplifying their calls to fund more research on gun violence after the recent mass shootings in Ohio and Texas, but Senate Labor-HHS-Education Appropriations Chairman Roy Blunt suggested Thursday he wouldn’t support new funding in that area.

The dispute over $50 million for gun violence prevention research could pose an additional challenge in the effort to avoid a government shutdown this fall.

Senate bill aims to protect taxpayers from costly drugs
Seeks to help Medicare control costs so premiums can remain stable

Congress this year could enact the biggest overhaul of Medicare’s prescription drug benefit since it was first established in 2003. If successful, seniors — and taxpayers — would be more insulated against the cost of the most expensive drugs. 

One proposed change is meant to help Medicare control the costs it absorbs so that the program’s premiums can remain stable despite increasing drug prices. Supporters of the drug program tout its low premiums, with the Trump administration and the private insurers who run Part D recently highlighting that average consumer premiums will fall in 2020.

HHS outlines drug import plans as Canada ratchets up concern
Canadians are worried that drugmakers could try to raise prices on the drugs sold there

The Trump administration on Wednesday announced plans to help states and others import lower-cost drugs from Canada, a popular but controversial idea that President Trump has embraced but that the Canadian government has pushed back on.

The plans outlined Wednesday will offer guidelines for setting up drug importation programs, but they also highlighted the challenges of this approach to lowering drug prices for consumers in the United States.

Finance advances drug price measure with tepid GOP support
Only six of the panel’s 15 Republicans voted to advance the measure

The Senate Finance Committee on Thursday approved, 19-9, a draft bill meant to reduce the cost of drugs in Medicare and Medicaid.

Only six of the panel’s 15 Republicans voted to advance the measure, joining all 13 Democrats. The most controversial amendments to the measure were rejected on mostly party-line votes.

Juul under continued scrutiny over flavors, marketing tactics
Juul officials will appear before panel Thursday and will likely address Wednesday allegations

The popular e-cigarette Juul is under renewed scrutiny by Congress thanks to two days of hearings that could pressure lawmakers to act on e-cigarette flavors that appeal to young people.

On Wednesday, the House Oversight and Reform Economic and Consumer Policy Subcommittee heard from witnesses about the company’s efforts to attract some vulnerable populations, namely teenagers and American Indians.

Finance drug price bill faces GOP resistance before markup
Proposals target Medicare drug prices

The Senate Finance Committee on Tuesday outlined a long-anticipated drug price bill, but a planned Thursday markup may not go smoothly because of Republican discontent with the measure.

The bill is meant to slow the growth of Medicare’s prescription drug spending, limit cost-sharing for Medicare beneficiaries, and make it easier for state Medicaid programs to pay for expensive treatments, according to a summary.