Pharma – Corporations and Health Watch

In Runup to 2020 election, Renewed Action to Regulate the Pharmaceutical Industry

Posted on May 30, 2019 by Corporations and Health Watch

Overt the last several years, the pharmaceutical industry has been accused of inappropriately and misleadingly advertising prescription drugs to consumers, charging exorbitant prices, paying competitors not to release less expensive generic drugs, and negotiating trade agreements that benefit the industry at the expense of the public. As public concern about these practices grows and as the 2020 election gets closer, Big Pharma is getting closer scrutiny.

A few recent actions illustrate this new climate. Earlier this month, reports The New York Times, the Trump administration announced that for the first time will, it will require pharmaceutical companies to include the price of prescription drugs in television advertisements if the cost exceeds $35 per month. The move is the most visible action the administration has taken so far to address the rising cost of prescription drugs. It has been a key issue for American voters and one that both Republicans and Democrats have vowed to address.

In Congress, Reps. Judy Chu (CA-27) and Devin Nunes (CA-22) last month introduced the Sunshine for Samples Act of 2019. This bill would amend the Sunshine Act, which requires pharma companies to report payments to doctors, to require companies that manufacture drugs, devices, biologics, or medical supplies to publicly make available the number and value of free drug samples given to health care providers and charities each year. The bill closes a loophole in the Sunshine Act and does not prevent drug and device manufacturers from continuing to provide free samples, nor does it add any new burdens to providers under the Open Payment Programs.

Both the Federal Trade Commission and Congress have also acted to oppose “pay for delay” a costly legal tactic that more and more branded drug manufacturers have been using to stifle competition from lower-cost generic medicines. These drug makers have been able to sidestep competition by offering patent settlements that pay generic companies not to bring lower-cost alternatives to market. Last month , Congressman Jerrold Nadler introduced H. R. 2375 , the Preserve Access to Affordable Generics and Biosimilars Act. The bill proposes to prohibit prescription drug companies from compensating other prescription drug companies to delay the entry of a generic drug, biosimilar biological product, or interchangeable biological product into the market.

These recent actions suggest that the 2020 election will provide public health professionals and advocates with opportunities to educate the American people and elected officials about the practices of the pharmaceutical industry and to counteract pharma’s extensive spending to influence Congress.

Round up of Bayer’s recent legal woes from Monsanto

Posted on April 16, 2019 by Corporations and Health Watch

Agricultural Application Trends of Glyphosate in the United States According to U.S. Geological Survey (USGS) Data Credit from new ATSDR Report on Glyphosate

A French court has ruled that Monsanto was liable for the sickness of a farmer who inhaled one of its weed killers, in another legal setback for the Bayer-owned business over health claims, reports Reuters.

In the latest stage of a decade-long legal tussle, the appeals court in Lyon on Thursday found in favor of farmer Paul Francois’ claim that Monsanto’s Lasso weed killer had made him sick and that the product’s labeling had been inadequate. Francois, 55, says he suffered neurological problems, including memory loss, fainting and headaches, after accidentally inhaling Lasso in 2004 while working on his farm.

“Mr. Francois justifiably concludes that the product, due to its inadequate labeling that did not respect applicable regulations, did not offer the level of safety he could legitimately expect,” the court said in its ruling.

Another Reuters story reported that Bayer said it would comply with a U.S. federal judge’s order to enter mediation with a plaintiff who claims the company failed to warn against an alleged cancer risk from its Roundup weed killer. Bayer has seen $34 billion wiped off its market value since August, when a first U.S. jury found Bayer liable because Monsanto, the Creve Coeur-based company acquired by Bayer for $63 billion last year, had not warned of the alleged risk from Roundup, which is based on active ingredient glyphosate. It suffered a similar courtroom defeat last month and more than 10,000 cases are pending.

U.S. District Judge Vince Chhabria, who presided over the first two cases in federal court, said in a filing dated Thursday that Bayer and another plaintiff, Elaine Stevick, were ordered to start confidential mediation.

A third Reuters post reported that one of Bayer’s largest shareholders tore into the company’s management on Wednesday for underestimating the legal risks of its takeover of Monsanto, setting the stage for a fiery annual general meeting after a 30 percent plunge in the shares. “It’s quite drastic when a takeover triggers such value destruction and reputational damage so quickly. There can be no talk of a successful takeover anymore,” Ingo Speich, the head of sustainability and corporate governance at Deka Investment, told Reuters.

“What’s startling is that things have effectively moved beyond management’s control because we’re now at a point where the decisions over future development are made in court rooms,” he said, adding Bayer had clearly underestimated the risks.

Finally, a public health agency of the U.S. Department of Health and Human Services (DHHS), the Agency for Toxic Substances and Disease Registry (ATSDR), released the long-awaited Draft Toxicological Profile for Glyphosate. The report supports and strengthens the 2015 cancer assessment of another health agency, the International Agency for Research on Cancer (IARC).

As the environmental group NRD Cnotes, a pattern is emerging: non-industry experts (Zhang et al 2019) and health agencies IARC and ATSDR are finding a link with glyphosate and cancer; whereas, regulatory agencies are lining up with Monsanto and Bayer that it does not cause cancer, even when reviewing the same scientific evidence.

Can litigation change pharma practices that contribute to opioid epidemic?

Posted on December 20, 2017 by Corporations and Health Watch

Credit

As journalistic and legislative scrutiny of the role of the pharmaceutical industry in the opioid epidemic continues, several new reports focus on the potential of litigation to curb Big Pharma abuses.

In The New England Journal of Medicine, Rebecca Haffajee and Michelle Mello, two public health lawyers, examine drug companies’ liability for the opioid epidemic. They describe five legal rationales for litigation against opioid makers and distributors that federal and state government agencies have used:

Blaming the industry for unreasonably interfering with public health by oversaturating the market with drugs and failing to guard against misuse and diversion,
Charging the industry with deceptive marketing that makes false claims about effectiveness and addictiveness,
Accusing the industry for lax monitoring of suspicious opioid orders, a potential violation of the federal Controlled Substance Act,
Asserting that the industry continued to promote opioid use despite mounting evidence lining the product to adverse health outcomes,
Alleging that the industry accrued profits at the government’s expense through unfair business practices.

The authors outline some of the challenges facing litigation against opioid manufacturers but conclude that “litigation could help alleviate the opioid epidemic by changing industry practices and building public awareness.”

In an Oklahoma lawsuit recently described in The New York Times, a lawyer is using the Cherokee Nation tribal court to sue Walmart, Walgreens and CVS Health, as well as McKesson and other major drug distributors, for violating federal drug monitoring laws(reason 3 above) and enabling prescription opioids to flood into the Cherokee nation. “I believe these companies target populations” Todd Hembree, the Cherokee Nation attorney general, told The New York Times. “They know Native Americans have higher rates of addiction. So when they direct their product here, they shouldn’t be surprised to find themselves in a Cherokee court.”

The Washington Post and 60 Minutes investigated the failure of the U.S. Department of Justice to follow the recommendation of a Drug Enforcement Agency task force working across 11 states to revoke registrations to distribute controlled substances at some of the 30 drug warehouses of The McKesson Corporation, the nation’s largest drug company. The DEA team wanted to fine the company more than $1 billion and bring the first criminal case against a drug distribution company. Instead, reports The Post, “top attorneys at the DEA and the Justice Department struck a deal earlier this year with the corporation and its powerful lawyers, an agreement that was far more lenient than the field division wanted…. Although the agents and investigators said they had plenty of evidence and wanted criminal charges, they were unable to convince the U.S. attorney in Denver that they had enough to bring a case.”

Note to Corporations and Health Watch readers: Our next post will be on January 3,2018. Happy New Year!

Growing Drug Industry Influence on FDA

Posted on December 14, 2017 by Corporations and Health Watch

Has the growing reliance of the U.S. Food and Drug Administration on industry user fees changed how the pharmaceutical and medical device industries influence FDA regulation? A review in The New England Journal of Medicine charts changing industry influence from the Prescription Drug User Fee Act (PDUFA)of 1992 to the recent sixth re-authorization of PDUFA by President Trump this year. The authors conclude that although 25 years of industry funding have shortened regulatory timelines, the user-fee model has fundamentally changed the way the FDA interacts with the drug industry. These changes may increase the risk that unsafe or ineffective drugs or medical devices enter the market.

Consumer Access to Affordable Medicines Is a Public Health Imperative, Says New Report

Posted on December 6, 2017 by Corporations and Health Watch

Consumer access to effective and affordable medicines is an imperative for public health, social equity, and economic development, but this need is not being served adequately by the biopharmaceutical sector, says a new report from the National Academies of Sciences, Engineering, and Medicine. The report offers recommendations to improve the affordability of prescription drugs without discouraging the development of new and more effective drugs for the future. “Over the past several decades, the biopharmaceutical sector in the United States has been successful in developing and delivering effective drugs for improving health and fighting disease, and many medical conditions that were long deemed untreatable can now be cured or managed effectively,” said Norman Augustine, chair of the committee that conducted the study and wrote the report. “However, high and increasing costs of prescription drugs coupled with the broader trends in overall medical expenditures … are unsustainable to society as a whole. Our report seeks to address the market failures that currently permeate the biopharmaceutical sector, such as lack of competition due to distortions in the application of the patent protection process, the imbalance between the negotiating power of suppliers and purchasers, and the convoluted structure of the supply chain. Although changes within the current system will be demanding, they are likely to better serve the nation.”

Don’t let pharma take down a new Maryland price gouging law

Posted on September 13, 2017 by Corporations and Health Watch

In May, Maryland became the first state to take action against the alarming trend of price gouging of off-patent brand-name and generic drugs, writes Jeremy Greene in an op-ed in The Washington Post. The state’s concise new law, which permits the attorney general to argue in front of a court when the price of an older essential medication increases so precipitously as to “shock the conscience,” passed with overwhelming bipartisan votes and broad popular support. The generic pharmaceutical industry would prefer to see it overturned. While the problem of pharmaceutical pricing is felt most keenly in newer specialty drugs that can cost more than $30,000 a year, interpretations of federal patent law limit the ability of states to protect residents from price increases in these newer drugs whose monopolies are protected by patents.

Massachusetts consumer and health care groups called on lawmakers to rein in skyrocketing prescription drug prices

Posted on July 12, 2017 by Corporations and Health Watch

MASSPIRG, Health Care For All, Health Law Advocates and others urged the Massachusetts Legislature’s Joint Committee on Health Care Financing to support S.652, An Act to promote transparency and prevent price gouging of pharmaceutical drug prices. The bill requires pharmaceutical manufacturers to disclose detailed information on the underlying cost components and pricing of the most expensive drugs including costs of production, R&D, marketing, rebates and discounts, and prices charged to purchasers outside of the U.S., among other information. The bill also authorizes intervention by state health care agencies and the Attorney General’s Office when pricing practices are determined to be gouging or unjustified. “Skyrocketing prescription drug prices are leading to higher health care costs for Massachusetts residents,” said Deirdre Cummings, Legislative Director at MASSPIRG. “In fact, according to an analysis of state data we submitted as testimony to the committee, rising pharmaceutical prices have a disproportionately high impact on Massachusetts health care premiums.”

EpiPen: “Do what’s right, not what’s easy”?

Posted on June 7, 2017 by Corporations and Health Watch

After the national outrage over EpiPen’s increase of the price of a box epinephrine injections to $609 last August, Mylan, the manufacturer, promised to live up to its motto of doing what’s right, not what’s easy. But, writes Charles Duhigg in The New York Times, last week regulators said the company had most likely overcharged Medicaid by $1.27 billion for EpiPens and the retail price of a box was still $609. The device contains about $1 of the drug epinephrine.

Big Pharma by the Numbers

Posted on May 31, 2017 by Corporations and Health Watch

A recent article in The New York Times provided insights into the pharmaceutical industry’s efforts to ensure that any new policies to lower drug prices would not hurt their profits.

In the first quarter of this year, the pharmaceutical and health products industry spent $78 million on lobbying, 14% more than in the same period last year.

In the 2016 election cycle, the industry contributed more than $58 million to the election campaigns of members of Congress and presidential candidates, a 20% jump from the 2012 cycle

The industry pays 1,100 lobbyists, more than two for each member of Congress.

Last year Representative John Shimkus, Republican from Illinois, helped persuade the Obama Administration to kill a project that would have lowered drug prices in Medicare Part B, which spent $24.6 billion on prescription drugs in 2015. In the last election cycle, Shimkus received $300,00 in drug industry contributions.

The Powerful Corporations Pushing to Unravel Protections for Consumers, Public Health, and the Environment

Posted on May 11, 2017 by Corporations and Health Watch

Source

In mid-May, writes the Center for American Progress, the Senate Homeland Security and Governmental Affairs Committee is scheduled to consider the Regulatory Accountability Act, or RAA, a dangerous piece of legislation that will make it harder—if not impossible—for federal agencies to do their jobs to protect consumers from unscrupulous business practices; protect the environment from pollution; and protect public health from exposure to toxic chemicals and unsafe food. Although the Senate sponsors are working to position the bill as moderate relative to its House companion, it is far from reasonable and will open new doors for powerful corporations to block federal agencies trying to serve the public interest. During the first three months of 2017, most of the largest trade associations in the country walked the halls of Congress pushing for the RAA. If this bill were to become law, the biggest winners would be the powerful corporations that have lobbied to pass it.