Podcast: KHN’s ‘What The Health?’ Drug Prices Are Rising Again. Is Someone Going To Do Something About It?

Many drugmakers have announced price increases with the start of the new year. The new Congress wants to do something about that. And even though both Republicans and Democrats want to address the politically potent issue of drug prices, it is unclear what they might be able to agree on.

Battle lines are forming between the House and Senate on the matter of abortion. The House is led by abortion-rights supporters and, since the election, the Senate has become slightly more against abortion.

And even though the majority of the Department of Health and Human Services remains unaffected by the partial government shutdown, the lapse of funding for other agencies is having spillover effects on health programs.

This week’s panelists for KHN’s “What the Health?” are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Alice Ollstein of Politico.

Among the takeaways from this week’s podcast:

  • The biggest conflict among Republicans and Democrats on the drug issue centers on the GOP’s reluctance to give the government a role in directly negotiating prices. Adding to the pressure is the clear indication that the issue will be front and center in the 2020 campaign.
  • Some states, such as California, are looking to find ways to bring down drug costs on their own. California Gov. Gavin Newsom, a Democrat, has proposed that the state have direct negotiations with drugmakers. Such efforts could mean cutting off consumers’ access to some drugs, if manufacturers don’t agree to a price the state likes, and that is a painful choice for officials and patients.
  • When House committee assignments were released this week, women were appointed to lead many of the key panels that have a hand in health policy, including the chairman and top Republican on the Appropriations Committee and two Energy and Commerce subcommittees.
  • The House Democratic Caucus now has more liberal members and fewer conservatives, so the party’s efforts to roll back restrictions on abortion are likely to be more robust. That could also trigger some big battles with Republicans through the legislative session.
  • Senate Majority Leader Mitch McConnell (R-Ky.) is putting a bill on the Senate floor that would make permanent the Hyde Amendment — which bars federal funding of abortions in nearly all circumstances. But it seems unlikely that bill could be passed by the Senate, where it needs 60 votes, and even some Republicans are believed to oppose it.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read too:

Julie Rovner: Bloomberg News’ “This JPMorgan Health Conference Is So Packed Attendees Are Meeting in the Bathroom,” by Kristen V Brown

Joanne Kenen: The New York Times’ “The Strange Marketplace for Diabetes Test Strips,” by Ted Alcorn

Margot Sanger-Katz: Kaiser Health News’ “Patients Turn To GoFundMe When Money And Hope Run Out,” by Mark Zdechlik

Alice Ollstein: The Washington Post’s “Federal Officials Launch Audit of D.C. Government’s Opioid Grant Spending,” by Peter Jamison

Kaiser Health News

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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HQ Trivia and Vine co-founder Colin Kroll dead at 34 of apparent drug OD

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Technology News & Reviews | New York Post

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Government Investigation Finds Flaws In the FDA’s Orphan Drug Program

The Food and Drug Administration has failed to ensure that drugs given prized rare-disease status meet the intent of a 35-year-old law, federal officials revealed in a report Friday.

The Government Accountability Office, which spent more than a year investigating the FDA’s orphan drug program, said “challenges continue” in the program that was created to spur development of drugs for diseases afflicting fewer than 200,000 patients.

The investigation began after a request from three high-profile Republican senators last year, in the wake of a KHN investigation. KHN found that the program was being manipulated by drugmakers to maximize profits and to protect niche markets for medicines being taken by millions.

The GAO uncovered inconsistent and often incomplete reviews early in the process of designating medicines as orphan drugs and recommended “executive action” to fix the system. In some cases, FDA reviewers failed to show they had checked how many patients could be treated by a drug being considered for orphan drug status; instead, they appeared to trust what drugmakers told them.

In response to GAO’s probe, the FDA issued a statement saying it agreed with the report recommendations regarding documentation and that the agency is “streamlining our processes.” The agency declined requests for interviews. In a comment included with the report, Matthew Bassett, assistant secretary for legislation at the Department of Health and Human Services, said HHS agreed with GAO’s recommendations.

John Dicken, director of the GAO’s health care team, said the focus of the report is “ensuring that the intent of the law is being met.”

The FDA’s rare-disease program began after Congress overwhelmingly passed the 1983 Orphan Drug Act to motivate pharmaceutical companies to develop drugs for people who lacked treatments for their conditions. Rare diseases had been ignored by drugmakers because treatments for them weren’t expected to be profitable. The law provides fee waivers, tax incentives for research and seven years of marketing exclusivity for any drug the FDA approves as an “orphan.”

The incentives, though, have proven to be more powerful and highly coveted than expected, said Avik Roy, president of the Foundation for Research on Equal Opportunity, a conservative think tank.

Many people are “starting to wonder whether or not the Orphan Drug Act over-corrected for the problem,” Roy said, noting that a third of all pharmaceutical spending in the U.S. will be on so-called rare-disease medicines in 2020.

GAO analysts examined FDA records for 148 applications submitted by drugmakers for orphan drug approval in late 2017. FDA’s reviewers are supposed to apply two specific criteria — how many patients would be served and whether there is scientific evidence the drug will treat their disease.

In nearly 60 percent of the cases, the FDA reviewers did not capture regulatory history information, including “adverse actions” from other regulatory agencies. The FDA uses experienced reviewers, Dicken noted, who may already know the history of certain submitted drugs and not see the need to document it.

And 15 percent of the time FDA reviewers failed to independently verify patient estimates provided by the drugmaker.

Of the 148 records the GAO reviewed, 26 applications from manufacturers were granted orphan status even though the initial FDA staff review was missing information.

“It is tempting to think that perhaps those approvals were sort of granted routinely without sufficient scrutiny,” said Bernard Munos, senior fellow at FasterCures and the Milken Institute.

By contrast, early Orphan Drug Act advocate Abbey Meyers said she was not concerned about the lack of population estimates because many rare diseases lack population studies that show how common a disease is.

Rather, Meyers said, she’s “disappointed that there is no government-funded agency that is willing to finance” such research.

The GAO investigation began after Scott Gottlieb, who took over as FDA commissioner in May 2017, announced a “modernization” of the rare-disease program.

Critics have long complained that drugmakers game the FDA’s approval process for orphan drugs. In January 2017, the KHN investigation, which was co-published and aired by NPR, revealed that many orphan drugs aren’t entirely new and don’t always start as treatments for rare diseases.

The GAO report, while not analyzing the same years, found that 38.5 percent of orphan drug approvals from 2008 to 2017 were for drugs that had been previously approved either for mass-market or rare-disease use. About 71 percent of the drugs given orphan status were intended to treat diseases affecting fewer than 100,000 people.

KHN’s investigation found that popular mass-market drugs such as cholesterol blockbuster Crestor, Abilify for psychiatric conditions, cancer drug Herceptin and rheumatoid arthritis drug Humira, the best-selling medicine in the world, all won orphan approval yet were already on the market to treat common conditions.

In addition, more than 80 orphan drugs won FDA approval for more than one rare disease — or several — each one with its own bundle of rich incentives.

Genentech’s Avastin, a cancer treatment approved for mass-market use in 2004, won three more orphan-designated approvals this year for the treatment of three rare forms of cancer. It now has 11 approved orphan uses in all, and exclusive protections that keep generics at bay won’t run out until 2025.

Sens. Orrin Hatch (R-Utah), Chuck Grassley (R-Iowa) and Tom Cotton (R-Ark.) sent a letter in March 2017 asking the GAO to investigate the program and find out whether Congress’ original intent for it was still being followed.

“Despite the success of the Orphan Drug Act, 95 percent of rare diseases still have no treatment options,” Hatch said in a statement Friday. “I hope that my colleagues will utilize this [GAO] report as they work to strengthen the accomplishments of the Orphan Drug Act and encourage developers to continue their investment in this patient population.” The GAO report also mentioned concerns about prices, noting that “the ability to command high prices” was one reason the rare-disease market was growing so rapidly.

The average cost per patient for an orphan drug was $ 147,308 in 2017 compared with $ 30,708 for a mass-market drug, according to a 2018 EvaluatePharma report on the 100 top-selling drugs in the United States. Celgene’s chemotherapy drug Revlimid was the top-selling orphan with $ 5.4 billion in sales and $ 184,011 in revenue per patient.

“We have accepted culturally that it’s OK for a company to charge high prices for [orphan] drugs,” said Roy. “The end result is that a lot of these orphan drugs are $ 10 billion drugs, even though they are for rare diseases.”

From 2008 to 2017, more than half of the drugs granted orphan status were for cancer or blood disorders, according to the GAO report. And nearly two-thirds of drugs approved in the program were given expedited review processes, such as accelerated approval or fast-track designation.

Prior to announcing Gottlieb’s modernization plan, the FDA had a backlog of 138 drug applications for orphan status that had been waiting more than 120 days. The backlog was cleared in August 2017 after staff from across the agency stepped in to help.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Drug overdoses, suicides cause drop in 2017 US life expectancy; CDC director calls it a ‘wakeup call’

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CNN.com – RSS Channel – Health

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New Congress To Tackle Burning Health Care Issues, Including Drug Prices

Voters ranked health care as the top issue facing the country after the midterms, according to CBS News exit polling. KHN senior correspondent Sarah Jane Tribble joined “Red and Blue” anchor Elaine Quijano to discuss how Republicans and Democrats are responding to the American public’s call to action — with a focus on skyrocketing prescription drug prices. Tribble and Quijano also explored how the midterms bolstered Medicaid expansion in a handful of states.


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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Trump Adds A Global Pricing Plan To Wide Attack On Drug Prices, But Doubts Persist

President Donald Trump’s new pledge to crack down on “the global freeloading” in prescription drugs had a sense of déjà vu.

Five months ago, Trump unveiled a blueprint to address prohibitive drug prices, and his administration has been feverishly rolling out ideas ranging from posting drug prices on television ads to changing the rebates that flow between drugmakers and industry middlemen.

Thursday, Trump proposed having Medicare base what it pays for some expensive drugs on the average prices in other industrialized countries, such as France and Germany, where prices are much lower. The proposal is in the early stages of rule-making and awaiting public comments.

The U.S., Trump said, will “confront one of the most unfair practices, almost unimaginable that it hasn’t been taken care of long before this.”

The proposal was met with hope and skepticism, with several experts saying they were happy the administration was taking on Medicare Part B’s rising drug prices but questioning its approach.

Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said in an online post that the administration’s proposed solutions were unclear. And, he said, they would “face insurmountable challenges.”

While some industry watchers pointed to the announcement as a political move, Wells Fargo pharmaceutical analyst David Maris said that this is a broader effort by the president and his administration to attack the root causes of high drug prices.

“The reality is he could very easily not take this on and do what other administrations have done and let the prices keep rising.”

Trump, too, promised more to come and said he will soon announce “some things that will really be tremendous.” On Friday, Health and Human Services Secretary Alex Azar said that, as promised in the blueprint, there would be more changes to Medicare Part D, which covers most prescriptions. Ian Spatz, a public policy expert and senior adviser at Manatt Health, said the overall blueprint was “unprecedented in terms of how many different ideas and areas of ideas that it contained.”

Nothing would happen overnight. The proposal to require drug prices in TV ads could be delayed by litigation and notably, if implemented, does not include any penalties for companies who fail to post their prices.

The proposed rebate rule was delivered to the Office of Management and Budget in July. Matt Brow, president of industry consulting firm Avalere Health, said he expects the administration to publish the rule for comment by year’s end.

Trump’s international pricing plan is not as far along as the rebate proposal. Rather, it is an “advanced notice of proposed rule-making.” The proposed rule could come in spring 2019, and Azar said the new model could begin in late 2019 or early 2020.

Yet, on Friday, Azar signaled the proposal could change, telling an audience at the Brookings Institution that the administration is “open to any number of alternative ideas.”

Avalere’s Brow said there is a good chance the proposal will change significantly.

“The sweeping nature of the proposal makes the stakes higher and makes it harder to implement,” Brow said.

If the administration moves forward, it would bypass Congress and implement a pilot under the Center for Medicare & Medicaid Innovation’s purview. The pilot would phase in over five years and apply to 50 percent of the country. Azar said there would be no changes to Medicare benefits and no restrictions on patient access.

The proposal focuses on drugs covered under Medicare Part B, which are administered in hospitals, clinics and doctors’ offices. It also would alter the reimbursement formula for doctors and providers and would allow private-sector vendors to purchase drugs and then sell them to doctors and hospitals. Medicare would reimburse those vendors at the international pricing level.

Currently, doctors and hospitals administering Part B drugs are reimbursed the average price of a drug plus 6 percent. President Barack Obama’s administration attempted to alter Part B as well but drew intense lobbying opposition and eventually withdrew a proposed pilot project.

Allan Coukell, senior director for health programs at Pew Charitable Trusts, said removing incentives that reward doctors for purchasing costlier drugs and bringing in a new way to control prices “makes a lot of sense.” Drug spending within Medicare Part B reached $ 22 billion in 2015, and drug costs have increased by an average of 8.6 percent annually since 2007.

Stephen Ubl, president of the industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said imposing foreign price controls from countries with socialized health care systems would harm patients and hinder drug discovery and development.

Azar, a former executive at pharmaceutical manufacturer Eli Lilly, told reporters Thursday that “you may hear the tired talking points” that this will affect innovation. He disputed that idea, concluding that “less than 1 percent of pharma [research and development] could potentially be impacted by this change.”


KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News

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Kaiser Permanente Southern California Provides Numerous Drop-Off Locations for National Prescription Drug Take Back Day

PASADENA, Calif. — Kaiser Permanente Southern California facilities, in partnership with local law enforcement agencies, are encouraging community members to participate in “National Prescription Drug Take-Back Day” on Saturday, October 27, 2018, from 10:00 a.m. to 2:00 p.m.

“At Kaiser Permanente we remain actively involved in the total health of our Southern California community, and we feel it’s our responsibility to educate the community about the importance of responsibly disposing prescription drugs, while also raising awareness of the significant harm that comes from abuse of medications, “said Alan Kiyohara, vice president, Pharmacy Operations and Services for Kaiser Permanente Southern California. “Studies have shown that medicines that remain in the home are highly susceptible to misuse.”

DEA National Rx Take Back - Saturday, October 27 10 a.m. to 2 p.m. Visit deatakeback.com for more information.There are 16 Kaiser Permanente Southern California facilities participating as drop-off sites for Take Back Day. Earlier this year, 11 Kaiser Permanente facilities participated during the Take Back Day, where more than 6,700 pounds of unused and expired medications were collected.

These prescription drug take back events address vital public safety and public health issues while providing residents with a convenient and anonymous way to safely dispose of expired, unwanted, or unused medicines.

Rates of prescription drug abuse in the U.S. are alarmingly high, as are the number of accidental poisonings and overdoses due to these drugs. According to the Drug Enforcement Administration, more people started down the path of addiction through the misuse of opioid prescription drugs, and each year higher amounts of opioids are being turned in at the Take Back Day events.

Those unable to participate on October 27 can properly dispose of medications at drug disposal kiosks in Kaiser Permanente facilities throughout Southern California. Kiosks are available at Kaiser Permanente locations for public use during regular service hours.

A listing of additional drop-off locations available for public use can be found on the Drug Enforcement Administration website.


About Kaiser Permanente

Kaiser Permanente is committed to helping shape the future of health care. We are recognized as one of America’s leading health care providers and not-for-profit health plans. Founded in 1945, Kaiser Permanente has a mission to provide high-quality, affordable health care services and to improve the health of our members and the communities we serve. We currently serve more than 12.2 million members in eight states and the District of Columbia. Care for members and patients is focused on their total health and guided by their personal Permanente Medical Group physicians, specialists and team of caregivers. Our expert and caring medical teams are empowered and supported by industry-leading technology advances and tools for health promotion, disease prevention, state-of-the-art care delivery and world-class chronic disease management. Kaiser Permanente is dedicated to care innovations, clinical research, health education and the support of community health. For more information, go to: kp.org/share.

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AbbVie rheumatoid arthritis drug succeeds in late stage trial

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10.24.18 Where to buy toys for Christmas; Mobile check deposit rules; Prescription drug price disclosure

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http://www.acrx.org -As millions of Americans strive to deal with the economic downturn,loss of jobs,foreclosures,high cost of gas,and the rising cost of prescription drug cost. Charles Myrick ,the President of American Consultants Rx, announced the re-release of the American Consultants Rx community service project which consist of millions of free discount prescription cards being donated to thousands of not for profits,hospitals,schools,churches,etc. in an effort to assist the uninsured,under insured,and seniors deal with the high cost of prescription drugs.-American Consultants Rx -Pharmacy Discount Network News

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National Prescription Drug Take Back Day Southern California Drop-Off Locations

Location Event Time

Kaiser Permanente Los Angeles Medical Center

4760 Sunset Blvd, Los Angeles, CA 90027

Drop-off site located curbside

10 a.m. to 2 p.m.

Kaiser Permanente West Los Angeles Medical Center

6041 Cadillac Ave, Los Angeles, CA 90034

Drop-off site located at the 24-Hour Pharmacy turn-around

10 a.m. to 2 p.m.

Kaiser Permanente Panorama City Medical Center

13652 Cantara Street, Panorama City, CA 91402

Drop-off site located outside the Medical Offices 3

10 a.m. to 2 p.m.

Kaiser Permanente Woodland Hills Medical Center

5601 De Soto Ave, Woodland Hills, CA 91367

Drop-off site located at parking lot on the corner of De Soto Ave and Burbank Blvd

10 a.m. to 2 p.m.

Kaiser Permanente Anaheim Medical Center

3460 E. La Palma Ave, Anaheim, CA 92806

Drop-off site located at turn-around driveway of Kraemer Medical Office Building 1

10 a.m. to 2 p.m.

Kaiser Permanente Irvine Medical Center

6670 Alton Parkway, Irvine, CA 92618

Drop-off site located at turn-around driveway of Alton/Sand Canyon Medical Office Building 1

10 a.m. to 2 p.m.

Kaiser Permanente South Bay Medical Center

25825 South Vermont Ave, Harbor City, CA 90710

Drop-off site located in front of Parkview Building near the corner of Vermont Ave and Pacific Coast Highway

10 a.m. to 2 p.m.

Kaiser Permanente Riverside Medical Center

10800 Magnolia Avenue, Riverside, CA 92505

Drop-off site located in parking Lot B4 at corner of Magnolia Ave and Park Sierra Ave

10 a.m. to 2 p.m.

Kaiser Permanente Stockdale Medical Office Building

3501 Stockdale Highway, Bakersfield, CA 93309

Drop-off site located in the parking lot

10 a.m. to 2 p.m.

Kaiser Permanente Bellflower Medical Offices

9400 E. Rosecrans Ave. Bellflower, CA 90706

Drop-off site located in the circle area near Clark Ave. entrance

10 a.m. to 2 p.m.

Kaiser Permanente Baldwin Park Medical Center

1011 Baldwin Park Blvd, Baldwin Park, CA 91706

Drop-off site located near patient drop-off (medical center entrance)

10 a.m. to 2 p.m.

Kaiser Permanente Diamond Bar Medical Offices

1336 Bridgegate Dr, Diamond Bar, CA 91765

Drop-off site located near main entrance

10 a.m. to 2 p.m.

Kaiser Permanente San Marcos Medical Offices

400 Craven Road, San Marcos, CA 92078

Drop-off site located at Entrance C off Craven Road

10 a.m. to 2 p.m.

Kaiser Permanente Otay Mesa Medical Offices

4650 Palm Ave., San Diego, CA 92154

Drop-off site located at the east entrance of the campus

10 a.m. to 2 p.m.

Kaiser Permanente Fontana Medical Center

9961 Sierra Ave, Fontana, CA 92335

Drop-off site located curbside by the parking lot of Medical Office Building 4

10 a.m. to 2 p.m.

Kaiser Permanente Ontario Medical Center

2295 S. Vineyard Ave, Ontario, CA 91761

Drop-off site located curbside by the parking lot of Medical Office Building B

10 a.m. to 2 p.m.

 

 

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A man drank too much of an erectile dysfunction drug. It tinted his vision red

A man drank too much of an erectile dysfunction drug purchased over the internet and it tinted his vision red, USA Today reports. Doctors have been unable to fix it.
Health and Science

U.S.HEALTHCARE UPDATE:

Click today to request your free ACRX discount prescription card and save up to 80% off of your medicine!

SPECIAL DONATION REQUEST UPDATE:

Please help American Consultants Rx achieve it’s biggest goal yet of donating over 30 million discount prescription cards to over 50k organizations in an effort to assist millions of Americans in need. Please click here to donate today!