StemCell Therapy

With help from Rachana Pradhan and Dan Goldberg

House Speaker Nancy Pelosis drug bill passes the House, but the Senates another matter.

President Donald Trumps FDA pick sails through the Senate and into the soup of vaping and other hot issues.

FDA encourages a focus on pediatric cancer with a shift to molecular targets.

A message from the Partnership for Americas Health Care Future:

New polling shows that lowering costs is the top health care priority for American voters, but embracing a one-size-fits-all new government health insurance system be it Medicare for All, Medicare buy-in, or the public option would mean higher taxes for middle-class families. Get the facts: Learn more.

Happy Friday and welcome back to Prescription Pulse! Were in the home stretch of 2019, just need to get a little thing called government funding done. Know what pharma and device provisions could make it in? Send pharma news, tips and fun reads to Sarah Owermohle (sowermohle@politico.com or @owermohle) and Sarah Karlin-Smith (skarlin-smith@politico.com or @sarahkarlin).

PELOSI DRUG BILL PASSES AND ITS OFF TO THE SENATE GRAVEYARD House Democrats overcame infighting within their ranks Thursday, passing a bill that for the first time would require the government to negotiate prices for costly drugs. The sweeping measure from Pelosi, H.R. 3 (116), hands Democrats a legislative victory to tout in the 2020 electionson a Trump administration priority, no less.

The measure passed 230-192, with two Republicans breaking ranks to support the measure. Eight Democrats jumped party lines to vote for a GOP amendment to replace the bill with H.R. 19 (116), a bundle of bipartisan provisions like measures banning pay-for-delay deals or capping seniors out-of-pocket costs, while avoiding controversial moves like negotiation or price hike caps.

In the Senate, Mitch McConnell has already said the bill is dead on arrival. But the majority leader hasnt committed to taking up his chambers alternative, a bipartisan measure from Senate Finance leaders Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.).

Grassley jumped on the House bill Thursday afternoon, saying it would result in dozens fewer therapies coming to market and that his bill was the only way forward. The House has acted and now the Senate must act, Grassley said.

Trump made vague promises to cut drug prices, including allowing government negotiations, during his 2016 campaign. But several promises have since faltered: courts killed a rule to require prices in drug ads, and the administration discarded a rule eliminating rebates over concerns it would increase premiums. The White House has thrown its support behind Grassleys bill, but the senator has been unable to rally the GOP votes.

Democrats aim to seize control of the drug pricing narrative in 2020. I believe we need real, substantive reforms, said Rep. Katie Porter (D-Calif.), a freshman who flipped her Orange County district last year, "and for a while, so did our president.

HAHN SAILS THROUGH SENATE FDA has a new leader. The Senate voted 72-18 Thursday to confirm the nomination of Washington newcomer Stephen Hahn.

Unlike his predecessor Scott Gottlieb who ultimately won much praise from Democrats who hadn't supported his nomination Hahn has no track record of working and profiting from the drug industry. He also lacks the prolific bibliography Gottlieb accumulated over the years writing on FDA-related policy, making it harder for Democrats to oppose him. Plus, Democrats were eager to see the departure of acting FDA chief Brett Giroir, the HHS assistant secretary of health, a conservative who has backed reproductive health policies opposed by the left.

But will his popularity last? Hahns bipartisan support will be tested by challenging political and public health issues, most notably how to regulate the booming e-cigarette industry amid an outbreak of serious lung illnesses associated with some vaping products.

The Trump administration promised a ban of flavored vaping products in September but in November retreated from that position after an outcry from free-market advocates and the vaping industry.

Hahn offered few hints throughout his confirmation process on how he would deal with vaping or other controversial topics like whether FDA should permit the importation of drugs from overseas to lower medication costs.

NEW REQUIREMENTS FOR PEDIATRIC ASSESSMENTS OF CANCER MEDS The agency issued draft guidance Thursday outlining how it will implement a provision in a 2017 law designed to ensure more cancer drugs are studied in children. Earlier laws requiring pediatric studies of drugs developed for adults only applied if children suffered from the same disease. But most adult cancers rarely occur in children, leading to gaps in pediatric cancer drug development.

Molecular targets a game changer: Researchers have found that a molecular-targeted drug that works to treat one cancer in adults may treat a different cancer in children if the same molecular target is relevant to both.

Sponsors of new cancer drugs for adults will now need to submit a report on pediatric cancer investigations for the drug with their marketing application to FDA, if the agency determines the target to be substantially relevant to a pediatric cancer. The requirements apply to drug applications submitted on Aug. 18, 2020 or later.

The guidance described how FDA will determine whether a molecular target is relevant and explains what should be in an initial pediatric study plan. FDA says studies described in the plan should evaluate dosing, safety and preliminary efficacy.

PHRMA SUES OVER OREGON DRUG PRICE LAWS The drug lobby on Monday challenged as unconstitutional two Oregon laws aimed at boosting transparency around prescription drug prices and increases, Portland Business Journals Elizabeth Hayes reports.

A measure passed last year, OR HB4005 (18R), requires manufacturers to submit a report to the Oregon Department of Consumer and Business Services when a drugs price rises over a threshold, explaining the hike and listing costs for making and selling the medicine. A newer provision, OR HB2658 (19R), mandates that drugmakers give 60 days notice on price increases.

A coalition of hospitals, insurers and health care advocates backed the first bill, but PhRMA said both measures were misguided and unconstitutional. The state should focus on capping out-of-pocket costs or give patients more of the negotiated savings on drugs, it said in a release.

Colorado issues report on strategies to lower drug costs Potential quick win policies that the state may pursue include price transparency related to drug price increases or PBM payments; requiring drug rebates to be passed through to employers and patients; and aligning the states importation policy with a potential expansion of federal regulations that the Trump administration is pursuing. Colorado Gov. Jared Polis has made health cost containment a priority and is one of a handful of states pushing the Trump administration to allow importation of prescription drugs from Canada.

SUPREME COURT REJECTS ARIZONAS CASE AGAINST SACKLERS Mark Brnovich, Arizonas AG, had taken the unusual step of asking the nations top court to hear his lawsuit, which accuses the Sacklers, the family behind Oxycontin-maker Purdue Pharma, of funneling $4 billion from the drug company while it faced huge liability for its role in the opioid crisis. Arizona is one of thousands of jurisdictions suing Purdue, which has declared bankruptcy. A bankruptcy judge put a hold on pending lawsuits but Brnovich decided to try his luck with the justices anyway.

RESEARCHERS CRITICIZE FINANCIAL DEPENDENCE ON INDUSTRY A group of researchers has demanded that medical research, education and practice become independent of commercial influences, Politico Europes Judith Mischke reports. The international researchers, clinicians, regulators and citizen advocates warned in a British journal that while everyone wants to ground healthcare decisions in "trustworthy evidence," there are still "widespread financial conflicts of interest across medical research, education, and practice.

In the United States, about 60 percent of medical research is industry funded, they noted. In some cases, "published outcomes of industry-sponsored studies tend to favor sponsors products, creating a 'sponsorship bias' in the evidence base that overplays benefits and underplays harms, the group writes.

They offer two solutions: Governments should pass laws requiring public disclosure of company ties, or regulators should bar public health organizations from receiving industry funding.

A message from the Partnership for Americas Health Care Future:

More than 180 million Americans rely on employer-provided coverage and new polling shows a majority of voters would rather build on whats working in our current health care system than replace it with a one-size-fits-all new government-controlled health insurance system.

Whether its called Medicare for All, Medicare buy-in or the public option, American families would face unaffordable costs and lower quality care under a one-size-fits-all system the exact opposite of what they want. See the results from the tracking poll here:Learn more.

PRESCRIPTION DRUG FACTORIES POLLUTING WATERWAYS Wastewater treatment plants are not typically equipped to remove pharmaceuticals from the waterflow, and drug cocktails have shown up in rivers across the U.S., reports Stat News Natasha Gilbert. In one area downstream of a Morgantown, W. Va., plant, an anti-seizure medication was measured at nearly 90 times the amount considered safe for wildlife. Stat and Type Investigations identified Mylan, Pfizer, Teva and three others as drugmakers dumping substantial levels of pharmaceuticals into the watershed.

CAR-T MANUFACTURING PROBLEMS PLAGUE NOVARTIS Novartis has had to give away some of its CAR-T cell therapy, Kymriah, because the personalized blood cancer treatment, made from a patients immune cells, havent met FDAs specifications, Biopharma Dive reports. In those cases the company delivered the treatment as if were an unapproved drug, through an expanded access protocol. In other cases, the company hasnt been able to use the product its made at all. Novartis presented real-world data this week that showed that even when the product didnt meet specifications it could attack cancer with no increased safety risk. Manufacturing is just one of the hurdles for commercializing the personalized medicine, which costs $475,000 for leukemia and $373,000 for lymphoma.

More:
Pelosi drug bill passes ... and it's off to the Senate graveyard - Politico

This entry was posted on December 15, 2019 at 7:44 am and is filed under Personalized Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |