Andrew Siddons

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.

Drug price transparency prompts fight among Democrats
Dispute is partly a turf battle between two committees who want to produce legislation on a high-profile issue

A dispute among Democrats over competing drug price transparency bills is complicating an issue that should have been one of the least controversial parts of the congressional effort to lower health care costs.

Two panels that oversee health care issues each approved measures this year to require drug companies to reveal information when they increase prices. While consumer advocates note drawbacks with both, they clearly prefer a measure from the Energy and Commerce Committee by Rep. Jan Schakowsky, D-Illinois, over a similar Ways and Means Committee bill.

Congress is Trump’s best hope for drug pricing action
But divisions remain between Republicans and Democrats, House and Senate

An upcoming Senate bill is the Trump administration’s best hope for a significant achievement before next year’s election to lower prescription drug prices, but a lot still needs to go right for anything to become law.

Despite the overwhelming desire for action, there are still policy gulfs between Republicans and Democrats in the Senate, and another gap between the Senate and the House. And the politics of the moment might derail potential policy agreements. Some Democrats might balk at settling for a drug pricing compromise that President Donald Trump endorsed.

Papaya outbreak highlights FDA’s food safety challenge
‘Inability to track and trace foods with speed or precision’ is agency’s ‘Achilles’ heel’

Salmonella infections caused by contaminated papayas highlight the challenges federal officials face in fighting foodborne illness, as a law from nearly a decade ago meant to modernize the food safety system is starting to show its age. 

The Food and Drug Administration is trying to bring its efforts to track and prevent outbreaks in line with the technology now at its disposal. But because spending for next year is uncertain, Congress could make it difficult for the agency.

Trump order to make medical service costs more transparent
The order will require hospitals and insurers to provide more information on costs of medical services before patients receive them

President Donald Trump on Monday will issue an executive order directing his administration to put rules in place requiring hospitals and insurers to provide more information about the costs of medical services before a patient receives them.

The order will kick off a process at the Health and Human Services Department to develop rules for the transparency requirements. The new rules will be meant to require hospitals to publicly post charges for common items and services in a consumer-friendly manner, and to require insurers to inform patients about the amounts they must pay before services are actually provided.

Odd bedfellows share concerns over Pelosi drug plan
Conservatives and progressives wary of drug price arbitration, but for different reasons

Debate on e-cigarettes lights up 10 years after FDA tobacco law
Calls grow for agency, Congress to do more after spike in teen use

A decade after Congress gave the Food and Drug Administration the authority to regulate tobacco products, there is a growing sense that the law should be revisited to address a product that lawmakers barely knew about in June 2009: electronic cigarettes.

The tension lies in how to balance e-cigarettes’ potential benefits with their clear risks. While e-cigarettes may offer a less harmful alternative for adults who smoke combustible cigarettes, they can appeal to young people who never would have smoked.

McConnell introduces bill making the legal smoking age 21
“Youth vaping is a public health crisis,” Kentucky Republican says

Senate Majority Leader Mitch McConnell on Monday introduced a bill to raise the federal age for purchasing tobacco products, including e-cigarettes, to 21, increasing the chances that Congress will clear a significant smoking-related bill for the first time since a major tobacco control law was enacted a decade ago.

The bill comes amid growing concerns about the youth use of e-cigarettes, which reached record levels in 2018. That marked a troubling reversal of declines in smoking traditional cigarettes.

House health care bill puts generic drug industry in bind
Low-cost generic drug makers expected a floor vote on a signature bill, but the law is being packaged with two measures industry opposes

This was supposed to be a good week for the makers of low-cost generic drugs, as a bill that is one of their top priorities gets a House floor vote. Instead, the industry finds itself clouded by allegations of price fixing, and its signature bill is being packaged with two measures they oppose.

The bill that the House will take up Thursday combines three drug pricing measures with bills to strengthen the individual health insurance market.