A Proposal to Import Drugs from Other Countries Creates an Unusual Alliance in the Senate

A Proposal to Import Drugs from Other Countries Creates an Unusual Alliance  in the Senate | Kaiser Health NewsSource: Kaiser Health News, by Victoria Knight

Harmony is not often found between two of the most boisterous senators on Capitol Hill, Bernie Sanders (I-Vt.) and Rand Paul (R-Ky.).

But it was there at Tuesday’s Senate Health, Education, Labor and Pensions Committee markup of legislation to reauthorize the Food and Drug Administration’s user fee program, which is set to expire Sept. 30.

This user fee program, which was first authorized in 1992, allows the FDA to collect fees from companies that submit applications for drug approval. It was designed to speed the approval review process. And it requires reauthorization every five years.

Congress considers this bill a must-pass piece of legislation because it’s used to help fund the FDA, as well as revamp existing policies. As a result, it also functions as a vehicle for other proposals to reach the president’s desk — especially those that couldn’t get there on their own.

And that’s why, on Tuesday, Sanders took advantage of the must-pass moment to propose an amendment to the user fee bill that would allow for the importation of drugs from Canada and the United Kingdom, and, after two years, from other countries.

Prescription medications are often much less expensive in other countries, and surveys show that millions of Americans have bought drugs from overseas — even though doing so is technically illegal.

“We have talked about reimportation for a zillion years,” said a visibly heated Sanders. “This bill actually does it. It doesn’t wait for somebody in the bureaucracy to make it happen. It actually makes it happen.” He then went on for several minutes, his tone escalating, citing statistics about high drug prices, recounting anecdotes of people who traveled for drugs, and ending with outrage about pharmaceutical companies’ campaign contributions and the number of lobbyists the industry has.

“I always wanted to go to a Bernie rally, and now I feel like I’ve been there,” Paul joked after Sanders finished talking. He went on to offer his support for the Vermont senator’s amendment — a rare bipartisan alliance between senators who are on opposite ends of the political spectrum.

“This is a policy that sort of unites many on both sides of the aisle, the outrage over the high prices of medications,” added Paul. He said he didn’t support drug price controls in the U.S. but did support a worldwide competitive free market for drugs, which he believes would lower prices.

Even before Sanders offered his amendment, the user fee bill before the committee included a limited drug importation provision, Sec. 906. It would require the FDA to develop regulations for importing certain prescription drugs from Canada. But how this provision differs from a Trump-era regulation is unclear, said Rachel Sachs, a professor of law at Washington University in St. Louis and an expert on drug pricing.

“FDA has already made importation regulations that were finalized at the end of the Trump administration,” said Sachs. “We haven’t seen anyone try to get an approval” under that directive. She added that whether Sec. 906 is doing anything to improve the existing regulation is unclear.

Sanders’ proposed amendment would have gone further, Sachs explained.

It would have included insulin among the products that could be obtained from other countries. It also would have compelled pharmaceutical companies to comply with the regulation. It has been a concern in drug-pricing circles that even if importation were allowed, there would be resistance to it in other countries, because of how the practice could affect their domestic supply.

A robust discussion between Republican and Democratic senators ensued. Among the most notable moments: Sen. Mitt Romney (R-Utah) asked whether importing drugs from countries with price controls would translate into a form of price control in the U.S. Sen. Tim Kaine (D-Va.) said his father breaks the law by getting his glaucoma medication from Canada.

The committee’s chair, Sen. Patty Murray (D-Wash.), held the line against Sanders’ amendment. Although she agreed with some of its policies, she said, she wanted to stick to the importation framework already in the bill, rather than making changes that could jeopardize its passage. “Many of us want to do more,” she said, but the bill in its current form “is a huge step forward, and it has the Republican support we need to pass legislation.”

“To my knowledge, actually, this is the first time ever that a user fee reauthorization bill has included policy expanding importation of prescription drugs,” Murray said. “I believe it will set us up well to make further progress in the future.”

Sen. Richard Burr (R-N.C.), the committee’s ranking member, was adamant in his opposition to Sanders’ amendment, saying that it spelled doom for the legislation’s overall prospects. “Want to kill this bill? Do importation,” said Burr.

Sanders, though, staying true to his reputation, didn’t quiet down or give up the fight. Instead, he argued for an immediate vote. “This is a real debate. There were differences of opinions. It’s called democracy,” he said. “I would urge those who support what Sen. Paul and I are trying to do here to vote for it.”

In the end, though, committee members didn’t, opting to table the amendment, meaning it was set aside and not included in the legislation.

Later in the afternoon, the Senate panel reconvened after senators attended their weekly party policy lunches and passed the user fee bill out of the committee 13-9. The next step is consideration by the full Senate. A similar bill has already cleared the House.

FDA Grants Emergency Authorization For First COVID-19 Breathalyzer Test

FDA grants emergency authorization for first COVID breath test | KHQA

Source: USA Today, by Jeanine Santucci

Americans will be able to find out if they have COVID-19 with a breathalyzer test, the Food and Drug Administration announced Thursday.

The FDA granted an emergency use authorization to a test produced by InspectIR Systems that collects a breath sample and analyzes for chemical compounds associated with the coronavirus, the first of its kind to be authorized for use.

In a study of 2,409 people, the test correctly identified a positive COVID infection in 91.2% of cases and correctly identified negative samples 99.3% of the time, the FDA said in a release. A similar result was seen in a follow-up study focused on the contagious omicron variant of the coronavirus.

According to InspectIR, the test is performed by exhaling into a tube in a similar manner to blowing up a balloon and produces results within three minutes.

The FDA said the testing instrument is about the size of a piece of carry-on luggage, and that breath tests can be performed in doctor’s offices, hospitals, and other testing sites.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” said Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency.”

The FDA said a positive result yielded through the InspectIR COVID-19 breathalyzer should be confirmed with a molecular test.

FDA Mulls Drug Importation With States

Import Offices and Ports of Entry | FDASource: Axios, by Adriel Bettelheim

The FDA has started discussions with states over creating a way to import drugs from Canada — a policy the Biden and Trump administrations both embraced to bring down health costs but which experts regard as having limited impact.

The big picture: With President Biden’s drug pricing agenda stalled, importation could allow states to take advantage of lower drug prices abroad without the need for direct action to limit prices in the U.S.

  • Under one pathway, states, wholesalers and pharmacies submit importation proposals to HHS, which would be subject to safety and cost conditions.

Driving the news: The FDA last week held its first meeting with five states — Florida, Colorado, Vermont, Maine and New Mexico — that have submitted reimportation plans or are thinking about doing so, Politico first reported.

  • Biden’s executive order on promoting competition directed the FDA to work with states and Native American tribes on safely importing prescription drugs from Canada.
  • “The FDA is committed to working with states and Indian tribes that propose to develop … importation programs to reduce the cost of products to the American consumer while still protecting public health and safety,” an agency spokesman told Axios.

Yes, but: The Pharmaceutical Research and Manufacturers of America sued to block a 2020 federal rule that would facilitate importation, citing patient safety and other concerns.

  • Canada also said it has no plans to participate and has told drugmakers not to take steps that could lead to drug shortages there.

Cowen analyst Rick Weissenstein notes the Biden administration has been inconsistent on reimportation, supporting the idea in theory while arguing that it won’t work in legal briefs filed in response to the drug industry trade group’s legal challenge.

Our thought bubble: With Canadians officials adamant they won’t participate in the process, any importation plan is unlikely to actually bring down drug prices. The issue still could be politically appealing as the campaign season heats up.

Your Next COVID-19 Vaccine Will Be Different

Source: The Mercury News, by Lisa M. Krieger

After deploying four COVID-19 shots in a little more than two years, the nation is absorbing a troubling realization: That’s a pace that’s impossible to sustain.

This past week, experts began charting a path to a future that is less perfect – but more practical.

It means building a vaccine that targets more than one strain of the virus. It would reduce severe disease and death, but not prevent every infection. If the design is changed, all vaccines will be updated. Manufacturers will likely offer the same vaccine formulation to everyone, rather than a mélange of different products for different people on different schedules.

And the goal is to have it ready by next fall when the risk of illness is likely to soar. That’s a very tight deadline.

Faced with the triple threats of fading immunity, an evolving virus and holiday gatherings, “we have to be prepared, from a standpoint of national security, making sure that we can protect our population with a vaccine in hand,” Dr. Peter Marks told an expert advisory FDA committee on Wednesday.

What will that look like?

“If we settle down to one shot per year that combines COVID and flu, I think that will be sustainable,” said UC San Francisco infectious disease expert Dr. Peter Chin-Hong.

“Nobody will want to get a vaccine every six months,” he said. “So we have to change the strategy.”

The creation and distribution of COVID-19 vaccines will go down in history as one of medicine’s greatest achievements. Only one year after cases were first documented, a shot was available. Fifteen months later, an impressive total of four doses were available for many people: a two-dose primary series and two boosters.

But, with each announced dose, interest fades. While 77% of the eligible U.S. population has gotten one shot, that rate dips to 65% who have gotten two shots and only 50% who have gotten three shots. The fourth dose is just beginning to be rolled out.

Vaccine protection is fading, too. After every shot, our immunity follows the same disappointing downward trajectory. Vaccines that are 91% effective in preventing hospitalization during the first two months fall to 78% after four months – and, over time, keep declining.

This means that people who got their one shot back in early 2021 are increasingly vulnerable.

Funding also will fade. Today’s federal funding free-for-all strategy won’t continue indefinitely, predict experts. Costs will be shifted to private insurers. That puts pressure on efficiency and effectiveness.

Yet the virus is here to stay. And it will keep changing. The virus has mutated two to 10 times faster than the flu, depending on the strain, reported virologist Trevor Bedford of the Fred Hutchinson Cancer Research Center in Seattle. He said it will continue mutating a little or a lot – either is possible.

Initially, experts hoped that a three-dose regimen would offer long-term protection. That strategy works for measles, mumps, rubella, hepatitis B, HPV and other viruses.

But COVID is different because it changes more, said Chin-Hong. That creates special challenges for vaccination planning.

This means things must move fast. The FDA hopes to decide on the composition of a future vaccine in May or June. While some clinical trials of potential products are already underway, vaccine manufacturers need several months to produce enough doses of a reconfigured vaccine, according to Robert Johnson, director of an infectious disease division within the Department of Health and Human Services.

The panel agreed on these points:

• The promise of a new “bivalent” or “multivalent” vaccine.

There’s a diminishing return by repeatedly giving the same “monovalent” vaccine, which targets the original strain, especially as new variants emerge. It also seems unlikely that an omicron-specific booster is the best idea. The virus changes so frequently that it could quickly be out of date.

A better approach may be to design something that targets two or more strains of the virus, called a “bivalent” or “multivalent” vaccine. Such vaccines are already in the works at Moderna and Novovax.

“A multivalent vaccine is going to be important in hopefully prolonging the duration of protection,” said Dr. Mark Sawyer, professor of clinical pediatrics at UC San Diego.

• Therapeutics must play a growing role.

Rather than constantly adding vaccines, we should seek the help of antiviral drugs, monoclonal antibodies and other future therapies to treat infections to keep people out of hospitals.

With 80% protection against hospitalization in older and sicker adults, “I think we may have to accept that level of protection and then use other alternative ways to protect individuals with therapeutics and other measures,” said Amanda Cohn of the U.S. Centers for Disease Control and Prevention.

• Take a more unified approach to manufacturing.

Vaccine makers should target the same strains, using similar doses, panelists said. It will prove impossible to keep track of multiple vaccines with different compositions.

The CDC must take the lead in deciding when the vaccines are no longer effective against severe illness, said Dr. Paul Offit, professor of pediatrics at The Children’s Hospital of Philadelphia. “At some level, the companies kind of dictate the conversation here,” he said.

If a new vaccine is needed to respond to a scary variant, it won’t just be a booster. The whole two-dose “primary series” would be replaced.

Better data and new designs are needed.

Because we’re in a rush, we’re relying on what the data tells us about the immune response in blood. But we also need to get better at interpreting what these lab studies mean for protection out in the real world, said Dr. Hayley Ganz, professor of pediatrics at Stanford University Medical Center. Antibody counts are important, she said. But so are other parts of the immune system, as well as clinical outcomes.

Finally, we need to know what future products await us in the research pipeline, even if they are not yet FDA authorized.

“The current mRNA vaccines are great. They can be turned around quickly,” said infectious disease expert Dr. Ofer Levy of Boston Children’s Hospital. “But it may be that other platforms emerge that give broader protection. So as we move forward, we don’t want to bake in a system that excludes other types of vaccines.”

Bill Targets Pharma Tactics to Delay Generics

The Senate Judiciary Subcommittee held a hearing on S. 3056, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. The bill would allow generic-drug companies to bring actions in federal court to get the drug samples they need to develop generic versions of brand drugs. It would authorize judges to award damages. Proponents say that the bill would prevent brand drug manufacturers from abusing risk evaluation and mitigation strategies to block generic competition. It would encourage more development of generic and biosimilar drugs and reduce drug costs. “This legislation will help bring generics to market faster, which is key to reducing drug costs,” said Pharmaceutical Care Management Association (PCMA) president and CEO Mark Merritt.

The bipartisan legislation was introduced by Senators Charles Grassley (R-IA), Patrick Leahy (D-VT), Amy Klobuchar (D-MN), and Mike Lee (R-UT). The legislation is supported by a broad group of stakeholders, including the Generic Pharmaceutical Association, the Academy of Managed Care Pharmacy, Public Citizen, Consumers Union, and the Blue Cross Blue Shield Assn. PCMA also suggests these solutions to bring down drug prices:

  • Accelerate FDA approvals of drugs that face little or no competition.
  • Make copay coupons an illegal kickback for all insurance that receives any federal subsidy.
  • Modernize the Medicaid pharmacy to make it more like the commercial market and Medicare Part D.
  • Create new incentives for physicians to prescribe biosimilars.

Drug Spending Growth Reaches 8.5% in 2015

Total spending on drugs in the United States reached $310 billion in 2015, up 8.5% from the previous year, according to a report by the IMS Institute for Healthcare Informatics. The surge of new drugs remained strong last year, and demand for new brands was high. Savings were relatively low from branded drugs facing generic competition. Price increases on brands had a limited effect due to higher rebates and price concessions from manufacturers. Specialty drug spending reached $121 billion on a net price basis, up more than 15% from 2014. (Net-price spending does not relate to a patient’s out-of-pocket costs or the amount health plans pay for drugs. It estimates the amount received by pharmaceutical manufacturers so it reflects rebates, off-invoice discounts, and other price concessions that manufacturers make to distributors, health plans, and intermediaries.)

Manufacturers are accepting lower price increases on existing products. At the same time, spending on new brands continued at near-historic levels. Increasingly, healthcare is being delivered by different types of healthcare professionals and from different facilities while patients face higher out-of-pocket costs and access barriers. The study predicts mid-single digit growth for drug spending through 2020, driven by innovative treatments and offset by brands facing generic or biosimilar competition.

Heightened competition among manufacturers, along with more aggressive efforts by health plans and pharmacy benefit managers to limit price growth, resulted in significantly lower price increases than in prior years. The report also reveals the following:

  • Spending on specialty drugs has nearly doubled in the past five years, contributing more than two-thirds of drug spending growth from 2010 to 2015. Treatments for hepatitis, autoimmune diseases, and oncology drove increased specialty spending. The year 2015 saw a 21.5% spending increase for specialty drugs.
  • Forty-three new active substances were launched in 2015 with a third receiving orphan drug designations from the FDA. An additional 30 brands were launched last year, bringing new combination therapies, alternative dosing, and treatment administration options to patients. The strong momentum of breakthroughs and R&D productivity is reflected in the 2015 cohort of new drugs.
  • Total prescriptions dispensed in 2015 reached 4.4 billion, up 1% year over year. Demand was higher in some therapy areas, such as antidepressants and anti-diabetes, each of which increased about 10% in 2015.
  • Over the past five years, integrated-delivery networks have expanded their affiliations with healthcare professionals to increase negotiating power with insurers, save money, and drive pay-for-performance initiatives. More than 54% of healthcare professionals are affiliated with integrated-delivery networks. In the past five years, there has been a 115% increase in urgent care centers and pharmacy in-store clinics. The number of prescriptions written by nurse practitioners and physician assistants more than doubled over the past five years.
  • While brand price increases are expected to continue in the 10% to 12% range, they will be significantly offset by rebates, discounts, and other price concessions.
  • The are very bright prospects for innovative drugs becoming available through 2020. The late-phase pipeline holds 2,320 novel products, with an average 43 to 49 to be launched annually over the next five years.

How the FDA Is Driving Drug Price Hikes

The FDA’s backlog of 4,000 generic drug applications is hindering competitors who could hold prices down, according to a study by the National Center for Policy Analysis (NCPA). Also, older generic drugs are often made on aging production lines, which are sometimes shut down for maintenance. Lines can be stopped after the manufacturer is warned by the FDA that the facility is out of compliance with good manufacturing practices. The resulting shortage often drives prices higher.

Thousands of drugs predate the FDA’s approval process required under the 1938 Food Author and Drug & Cosmetics Act; many were grandfathered, but never officially approved.  NCPA senior fellow Devon Herrick says, “The FDA wants these cheap drugs off the market and replaced with more costly approved versions from any drug makers willing to conduct clinical studies on them.”

State regulations also bite consumers in the wallet. Generic substitution laws in some states make it harder for consumers to save. In the face of rising drug prices, many states have passed laws that worsen the situation, such as banning efficient pharmacy networks, restricting mail-order pharmacies, and restricting maximum allowable cost lists.

The NCPA study highlights several ways to lower America’s drug bills, including the following:

  • Clear the FDA’s backlog of applications to manufacture generic drugs.
  • Resist passing perverse regulations designed to protect local business.
  • Promote competition in the production of generic medications.

“Much of the recent rise in the price of generic drugs can be directly linked to regulatory and legal causes,” says Herrick. This study is Part II of Herrick’s in-depth examination of the rising costs of generic drugs.

Biosimilar Medications Could Save Billions

Over the next decade, the United States could save $44 billion by introducing competing biosimilar versions of complex biologic drugs, according to a report by the RAND Corporation. Biologics, which treat conditions, such as cancer and rheumatoid arthritis, are often effective, but expensive. Patient copays can be several thousand dollars a year. In 2011, eight of the 20 best selling drugs were biologics. Also, annual spending on the drugs has grown three times faster than spending for other prescription medications. Introducing biosimilar drugs into the U.S. marketplace is expected to increase competition and drive down prices, saving money for patients, health care payers, and taxpayers. However, savings are not expected to be as dramatic the as savings we have seen for an earlier generation of less-complex generic drugs.

The Affordable Care Act authorizes the FDA to develop a regulatory framework for approving biosimilar drugs. Draft materials released by the FDA suggest that not all biosimilars will be interchangeable with their original counterparts. In addition, nearly all biosimilars will require at least one head-to-head clinical trial to confirm similarity to the original biologic, which is a more-strenuous process than what is required for standard generics. A number of issues will determine the savings and who will benefit. One issue is how much the use of biologics grows as some patients switch to biosimilar drugs as they become more affordable. Patients will see some cost savings. But physicians and hospitals may also benefit because biologicals are often purchased by health providers and administered in clinics and other treatment settings. For more information, visit www.rand.org.

State Backs Reproductive Rights

California’s executive and legislative branches have thrown their support behind reproductive rights. First, the California Dept. of Managed Health care sent letters to carriers and colleges reminding them that insurance companies in the state can’t refuse to cover abortion. The announcement came after two Catholic institutions, Santa Clara University and Loyola Marymount University, decided to drop coverage for elective abortions for more than 2,000 employees.

Second, the California legislature passed the Contraceptive Coverage Equity Act, which strengthens the coverage for FDA-approved birth control methods under Obamacare. It now heads to the governor, who is expected to sign it. Senate Bill (SB) 1053 would expand access to the full range of FDA approved methods of birth control without restrictions or co-pays.  The measure was introduced by Senator Holly J. Mitchell (D-26) of Los Angeles and co-sponsored by California Family Health Council and the National Health Education Law Program.

California has had a law on the books since 1999 that requires health insurers to cover contraception along with other prescription drugs. The new measure goes even further to ensure that women can select their birth control method without being required to try other methods first. “We continue to see an alarming national trend of restricting access to women’s health care. In the aftermath of the disappointing Hobby Lobby decision, California, once again, has the opportunity to lead the nation with a legislative model to help women more effectively plan their families and futures with fair and consistent contraceptive coverage,” said Julie Rabinovitz, President and CEO of California Family Health Council.

Traditional Prescription Drug Spending Drops

In 2012, U.S. spending on traditional prescription drugs fell for the first time in more than 20 years, according to data by Express Scripts. Traditional prescription drug spending fell 1.5% in 2012 among the country’s commercially insured population. However, this decline was offset by an 18.4% increase in spending on specialty medications to treat more complex diseases, such as rheumatoid arthritis, cancer, and hepatitis C.

Glen Stettin, MD of Express Scripts said that the drop in traditional drug spending is due to the success of utilization management programs and a growing interest in generic medications, home delivery pharmacies, and more focused retail pharmacy networks. Stettin added, “Effective management solutions and increased drug competition are necessary…to rein in specialty drug costs…and increased drug competition, in the form of biosimilars, is necessary to offer more affordable medication.” Last year’s patent cliff ushered in lower-cost generic alternatives for many blockbuster medications and utilization increased for eight of the top 10 traditional therapy classes, while unit costs decreased in seven.

For the second consecutive year, the country spent more on prescription drugs for diabetes than for any other therapy class. Diabetes drug spending increased 11% in 2012, driven, in part, by unit cost increases for popular insulins. Spending on medications to treat attention disorders increased 14.2% in 2012. Utilization increased 8.8%, due largely to an increased number of adult patients. Unit costs increased 5.4% as a result of a 2012 shortage of active ingredients contained in many of the medications in this class.

While affecting fewer than 2% of the general population, specialty conditions in 2012 accounted for 24.5% of pharmacy benefit drug spending  — the highest percentage on record. Specialty medications often require specialized handling, frequent dosing adjustments, and intensive clinical monitoring and patient assistance. The costliest specialty category was for inflammatory conditions such as rheumatoid arthritis; drug spending increased 23%. This increase was driven by a 9% increase in utilization and a 14% increase in unit costs.

There was a 33.7% increase in hepatitis C spending, which is a bigger increase than any other major traditional or specialty therapy class. The increase is due almost entirely to two new drugs being introduced in May 2011. Express Scripts expects total spending on hepatitis C medications to increase 32.3% in 2013 and another 56.3% in 2014.

For cancer medications, utilization increased 3.4% and costs increased 22.3%. Driving much of the cost increases are new drugs that treat unique genetic profiles — a trend that increased in recent years.

In 2012, the Food and Drug Administration approved 22 new specialty drugs, many of which will cost more than $10,000 per month of treatment.

Doctors who are more likely to prescribe generic medications to Medicare patients are younger, see a large number of Medicare patients, and practice in Midwestern states such as Ohio, Illinois, and Michigan.

As more Americans seek treatment for drug and alcohol abuse, chemical dependence is now among the top 10 traditional therapy classes when it comes to Medicaid drug spending. At 24.3% in 2012, chemical dependence drugs account for the largest percentage increase in Medicaid drug spending.

Utilization of cancer medications increased 11.8% for Medicare patients in 2012, contributing to a 32.8% spending increase for this population. Medicare patients increased utilization of hepatitis C medications by 63.5% in 2012. Infection rates for the virus are more prevalent among patients born 1945 to 1965.

Medicaid spends more on asthma medication than on any other single condition. Total asthma spending increased 6.2%, driven largely by increased utilization.

Prices for the most highly utilized brand-name medications increased 12.5% in 2012, far outpacing the general inflation rate of 1.7%. During the same period, generic medication prices declined 24%. This 36.5 percentage point net inflationary effect is the largest single-year widening of brand and generic prices since Express Scripts began calculating its Prescription Price Index in 2008. The full report is available atwww.DrugTrendReport.com.

Last Updated 06/29/2022

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