JustCare

Tag: Generic drugs

  • Sanders calls for Justice Department to criminally enforce antitrust laws against Teva and other generic drug companies

    Sanders calls for Justice Department to criminally enforce antitrust laws against Teva and other generic drug companies

    Back in May, forty-four states filed a lawsuit against 20 generic pharmaceutical companies, including Teva, Pfizer, Novartis, Mylan for illegally conspiring to drive up generic drug prices as much as ten-fold on more than 100 generic drugs. Since then, Senator Bernie Sanders and Congressman Elijah Cummings have sent a letter to the Justice Department requesting it prioritize criminal enforcement of the antitrust laws against generic drug companies. Their goal is to bring down the price of generic drugs.

    The letter expresses deep concern about the Justice Department’s failure to enforce federal antitrust laws against generic drug companies. Only one company, Heritage, has been held to account for corporate criminal activity. And, that company was able to settle the case against it with a mere $225,000 criminal penalty–hardly enough to deter future bad conduct.

    Sanders and Cummings state that any civil enforcement by the Justice Department is insufficient if the charges against the 44 generic drugmakers have merit. Criminal enforcement will be needed.

    The state lawsuits included evidence that the generic drugmakers may have conspired to fabricate responses to Sanders’ and Cummings’ 2014 investigation regarding generic drug price hikes. It appears that Teva and other generic drugmakers responded to Sanders’ and Cummings’ queries with “polite f-u letters,” designed to obstruct the investigation. According to Sanders and Cummings, the generic drugmakers gave reasons for their price increases that were at best grossly misleading and may have been false statements to Congress.

    Sanders and Cummings are requesting a briefing by the Justice Department on June 21 as to how it is protecting the public from anticompetitive practices of the generic drugmakers. Sanders has a bill to lower all drug prices through international reference pricing, essentially having the US pay no more for drugs than the average of what other wealthy countries pay. Click here to see my Facebook video on drug pricing for Bernie Sanders.

    If you want Congress to rein in drug prices, please sign this petition.

    Here’s more from Just Care:

  • Before ordering generic drugs from Canada or any other country, check out US prices.

    Before ordering generic drugs from Canada or any other country, check out US prices.

    If you’re one of the millions of Americans who has bought lower-cost medication from Canada or another country, then you know you often can save big time. You also know that if the pharmacy is licensed, requires your prescription, and has been verified, that you are getting the medication you ordered. But before ordering generic drugs from Canada or any other country, check out US prices.

    PharmacyChecker.com verifies international online pharmacies and compares their prices with U.S. pharmacy discounted prices. Recently, it compared prices on 34 of the most commonly prescribed generics, to determine the best savings options for Americans paying out of pocket. Out of those generic drugs, PharmacyChecker found that 88% were cheaper in the US, and by an average discount of 68%.

    For example, the price for 100 pills of lisinopril 10mg, a popular blood pressure medication, (brand name Prinivil), for which Americans filled 110,000 scripts last year from a PharmacyChecker-accredited Canadian pharmacy was $72.84. (An Indian online pharmacy charges $30.) With a free PharmacyChecker Discount Card, it’s $10 in the US.

    Amlodipine besylate is another generic blood pressure medication, one that treats hypertension to prevent heart attacks, which goes by the brand name Norvasc. For 100 pills of the 5mg generic version, the price in Canada is $40. It’s $15 in the U.S. using a free discount card.

    Of course, your Medicare Part D or other drug coverage may cost you even less than the price of low-cost generics in the US. But, if it does not, you know what you can do!!!!

    Here’s more from Just Care:

  • Bi-partisan legislation could reduce drug middlemen profits, but unlikely to reduce drug prices

    Bi-partisan legislation could reduce drug middlemen profits, but unlikely to reduce drug prices

    Stat News reports that bi-partisan Senate legislation to address unexpected medical bills includes legislation that could bring down the profits of the middlemen who buy drugs from pharmaceutical companies on behalf of health insurers. But, the legislation does not hurt pharmaceutical company profits or in any way ensure uniformly lower drug prices. We need Congress to regulate drug prices.

    Sens. Lamar Alexander (R-TN) and Patty Murray (D-WA), who head the Senate health committee, have crafted a bill that would stop Pharmacy Benefit Managers (PBMs) from being able to keep for themselves the difference between the price the PBM charges an insurer, such as Medicaid, for a drug and the price it pays the pharmacy for the drug, “the spread.” The spread could be many times the pharmacy price, as Bloomberg reports.

    The bill does not appear to hurt pharmaceutical companies. Indeed, it could help them. They might be able to take advantage of this law to raise the wholesale price of drugs and profit more without affecting the price people pay for them.

    If this legislation is enacted, PBMs also would have to report more information about the amount they pay for drugs and the amount of the rebates they get. Their clients, Medicaid and commercial insurers, would receive all rebates and discounts. This would likely put an end to, or significantly reduce, rebates and discounts. It also could mean that insurers pay PBMs more for their services. Would it bring down drug prices?

    Under the legislation, PBMs would pay a penalty of $10,000 a day if they did not comply. For PBMs, $10,000 a day is a drop in the bucket. They are multi-billion companies for whom $3.65 million a year is chump change. In 2017, they earned $223.7 million from the spread on Ohio Medicaid alone.

    In October 2018, the Patient Right to Know Drug Prices Act became law. It forbids gag clauses, which have kept pharmacists from telling patients when the actual price of a drug is less than its copay.

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  • Pfizer, Teva and other generic drugmakers charged with illegally driving up drug prices

    Pfizer, Teva and other generic drugmakers charged with illegally driving up drug prices

    The New York Times reports that forty-four states filed a lawsuit against Teva, Pfizer, Novartis, Mylan and several other generic pharmaceutical companies for illegally conspiring to drive up generic drug prices as much as ten-fold. The suit charges that they were engaged in price-fixing for more than 100 generic drugs. If found guilty, what punishment would fit the crime?

    More than 12 pharmaceutical companies and their executives are implicated in the lawsuit. And, the state prosecutors claim that the executives were aware that their activities undermining competition in the generic drug market violated the law. They allegedly colluded to raise prices on all the drugs they could.

    These unwarranted and illegal price hikes on critical generic drugs drive up national health spending, hurt state and federal budgets and undermine the health and financial well-being of patients. 

    The complaint describes an “industry-wide” practice of colluding to raise prices that is “pervasive.” Not surprisingly, Teva and Pfizer deny all charges against them.

    Generic drugs whose prices were inflated include drugs to treat HIV, asthma, cholesterol, ADHD and cancer as well as blood thinners, contraceptives and antidepressants. Specifically, the following drugs:  lamivudine-zidovudine, budesonide, fenofibrate, amphetamine-dextroamphetamine.

    The attorneys general’s lawsuit was filed in the Federal District Court in Connecticut. In a tweet, William Tong, the Connecticut attorney general, said that the behavior of these generic drugmakers was “a highly illegal violation of antitrust laws.”

    Here’s more from Just Care:

  • How safe are generic drugs?

    How safe are generic drugs?

    An op-ed by Katherine Eban in The New York Times exposes the FDA’s lax regulatory oversight of generic drug manufacturing. It makes a compelling case that generic drugs that are manufactured abroad may not be safe. What is to be done?

    The FDA is extremely limited in its ability to oversee foreign generic drug manufacturing plants.  Yet, 90 percent of the drugs we take are generic. We depend upon them heavily. And, many are manufactured abroad.

    Back in 2012, the FDA’s Peter Baker took on the job of inspecting Indian generic drug manufacturing plants.  He wanted to understand best practices. Instead, he saw serious safety risks. And, he discovered false data and reports at 29 of the 38 generic drug plants he visited. More recently, he found a similar rate of fraud and deception in Chinese drug manufacturing plants.

    Generic drug manufacturers must comply with FDA regulations, including collecting and storing data about drugs as they are made. But, they too often do not comply, according to Eban, who reports extensive problems in India and China. For example, at one manufacturing plant, Baker saw that an employee was trying to bury data showing that the manufacturer knowingly distributed insulin containing metallic pieces from a defective machine. And, it continued to use that machine to manufacture other drugs. Shortly after Baker’s discovery, the FDA stopped all imports from that plant.

    As Baker continued his inspections, he discovered that fraud and deception were the norm at these generic manufacturing plants. He identified secret labs and false data at nearly 80 percent of plants. The FDA was receiving completely trumped up reports from the manufacturers. Around 40 percent of generic drugs sold in the US are manufactured in India.

    Moreover, the FDA reports that  80 percent of active ingredients in all drugs sold in the US are not made in the US. And, 40 percent of finished drugs are imported. Gabriel Levitt, president of PharmacyChecker.com told me that his company found that 71 of the 100 most frequently used brand-name drugs are not made in the US. 

    Eban writes that “In some instances, deceptions and other practices have contributed to generic drugs with toxic impurities, unapproved ingredients and dangerous particulates reaching American patients.” And, she says that the generic drugs are, in some cases, making patients in the US sicker.

    Eban doesn’t highlight concerns with brand-name drugs, even though many of their active ingredients are manufactured overseas as well, including India and China. And, some brand-name drugs manufactured in the US have been found to put patients at risk. In 2010, the government fined Glaxo-Smith Kline $750 million for intentionally selling 20 contaminated drugs that may not have been safe or effective. More recently, the FDA cited Pfizer for manufacturing and selling EpiPens that did not work properly, which may have led to the death of seven people.

    Between 2013 and 2018, the FDA has lightened the punishment on generic drug manufacturing plants that cook their books or otherwise make drugs that may be unsafe. It often asks the manufacturer to take “voluntary action” to address problems and allows their drugs to be sold in the US.

    Eban calls on the federal government to ban drugs in the US that are made in plants that do not comply with FDA regulations. That seems like a fair start. Another strategy would be for the federal government to manufacture the drugs itself, something it once did in some instances.

    Here’s more from Just Care:

  • Proposed Trump Rx policy will drive up people’s drug costs

    Proposed Trump Rx policy will drive up people’s drug costs

    The New York Times reports on a new proposed Trump administration policy that would drive up people’s drug costs further. It would raise the cap on total out-of-pocket costs for people with health care coverage under the Affordable Care Act. In addition, it would make it harder to qualify for a federal subsidy to offset people’s insurance premiums and reduce the size of the subsidy for those eligible.

    The Trump administration’s policy proposal would penalize people with health care coverage through the state health insurance exchanges, who use brand-name drugs when lower cost generics are available. It would allow insurers on the state exchanges to count only the generic drug’s copay amount towards a person’s total out-of-pocket costs even when the person paid a higher copay for a brand-name version of the drug.

    Maximum out-of-pocket costs for people would increase. Today, people’s annual out-of-pocket cap is $7,900. The Trump Administration policy would push it up to $8,200. And, how these costs are counted would change to push the cap still higher in practice. Any help people in the state health exchanges receive in the form of coupons or financial assistance to offset the cost of their drugs would not count towards their total out-of-pocket costs. Some insurers are already failing to count this assistance towards people’s out-of-pocket costs.

    This proposed policy change at first may appear to have merit. Pharmaceutical companies use drug coupons–which are not generally available to people with Medicare–as a means to get people to buy their high-cost drugs and drive up their profits. This is problematic when lower-cost drugs are as effective, killing generic competition and driving up overall health care costs. For this reason, these coupons are a problem.

    But, the coupons can be a lifesaver for people who otherwise could not afford their medications. A policy that makes them less effective is of no help to people who need them to afford their drugs. Some brand-name drugs do not have a lower-cost substitute. And, some people rely on drug coupons to pay for their generic drugs, which can be very expensive. 

    Without drug coupons, the Trump administration believes that the pharmaceutical industry will rein in high drug prices for fear they will lose market share. But, there is no evidence to support that theory. Pharmaceutical companies never seem to need to lower their prices. They find other strategies to sell their drugs at high prices.

    The most helpful government action to rein in drug costs is to step in to negotiate fair drug prices for everyone, as Senators Bernie Sanders and Elizabeth Warren have proposed in different Congressional bills they have introduced.

    If you want Congress to rein in drug prices, please sign this petition to Congress.

    Here’s more from Just Care:

  • Pharmaceutical companies use scare tactics to mislead public about generics

    Pharmaceutical companies use scare tactics to mislead public about generics

    Americans are always being sold, and health care products are no exception. It’s one thing when corporations are pushing the latest snack food or toothbrush, it’s another when they are pushing to make money in ways that endanger our health and well-being. The Washington Post reports that pharmaceutical companies have been using scare tactics to mislead the public about generic drugs and to keep lower-cost drugs off the market.

    We all know that pharmaceutical companies use all the tools in their arsenal to profit off of our health. They charge Americans prices that are double what they charge in other wealthy countries, which regulate drug prices. They pay Pharmacy Benefit Managers to put their higher-cost drugs on insurance company formularies and keep generics off. They pay researchers to help ensure papers are published promoting their latest drugs. They pay TV stations to promote their drugs. They pay disease organizations to support their high prices. They contribute to election campaigns of federal and state policymakers to protect against legislation that would eat into their profits. And, the list goes on.

    Now, they are said to be doing what they can to keep generic versions of their high-cost biologic drugs–biosimilars–off the market. They are misleading people. These generic biosimilar drugs are as safe and effective as the brand-name biologics. They are made with the same ingredients.

    Biologics are made with living cells. And, they can treat a range of life-threatening diseases, including cancer. But, they tend to be extremely costly, often costing many thousands of dollars.  Indeed, the majority of growth in prescription drug costs between 2010 and 2015 can be attributed  to biologics, including Humira.

    If the pharmaceutical companies succeed, it could keep these generics off the market, and many people will be forced to go without necessary treatment. They cannot afford the cost of the biologics; biosimilars could cost as little as half as much. Not surprisingly, drug spending is estimated to be between $54 billion and $200 billion higher over 10 years, if the biosimilars are not available.

    But, what’s curious is that it is the doctors who prescribe these drugs. And, they are perfectly well positioned to tell their patients that biosimilars are as safe and effective as biologics. The Washington Post article does not explain why doctors are not prepared to do so.

    FDA Commissioner Gottlieb suggested that the FDA could step in and issue warning letters to pharmaceutical companies if they are deliberately misleading people. But, it’s hard to imagine that will be helpful.

    Here’s more from Just Care:

  • Senator Warren and Congresswoman Schakowsky introduce bill to lower drug prices

    Senator Warren and Congresswoman Schakowsky introduce bill to lower drug prices

    Americans take way more generic prescriptions than brand-name drugs. But, all in, we spend a lot more on brand-name drugs. Ninety percent of generic drugs prescribed represent 25 percent of drug spending. Still, in instances in which there is little or no generic competition, generic drug costs can be sky high. Senator Elizabeth Warren and Congresswoman Jan Schakowsky have introduced a bill to dramatically lower generic drug prices when they are excessive.

    There is no compelling reason that Americans pay, on average, twice as much as people in other wealthy countries for our drugs. When generic drugs are costly, drugmakers cannot even claim that they need to recoup research and development costs. They are simply copying a drug that has already been developed.

    The Affordable Drug Manufacturing Act, the Warren-Schakowsky bill, curbs generic drug costs and establishes fair drug prices through the creation of a government drugmaker. If enacted, the government would either directly or, indirectly–through a contract with a generic drugmaker–manufacture generic drugs that are priced excessively in order to drive competition and bring down their price.

    The Affordable Drug Manufacturing Act provides for an Office of Drug Manufacturing which would be required to identify a minimum of 15 different generic drugs for which there is market failure—the drug is not being manufactured, there is a drug shortage or the drug is an “essential medicine” priced excessively. It would manufacture those drugs in its first year.

    Unsurprisingly, the trade association of generic drugmakers is opposed to this legislation. Instead of recognizing the failures of the generic drug market, it points to the failures of the brand-name drug market.  Fortunately, Senator Sanders and Congressman Khanna have introduced a The Prescription Drug Price Relief Act to lower the price of excessively priced brand-name drugs, which you can read about here.

    There is clear evidence of price-fixing or excessive pricing and potential collusion of drugmakers in the generic drug market. The US Justice Department and 45 states are currently investigating this issue, which some claim has cost consumers and businesses more than $1 billion. For example, there is a large investigation underway of Eli Lilly’s role in increasing the price of insulin. Even though insulin is more than 100 years old, its price keeps going up. The Warren Schakowsky bill specifies that insulin be among the drugs the federal government manufactures.

    Other Democratic bills to lower prescription drug prices have recently been introduced. Senators Jeff Merkley (D-OR), Kamala Harris (D-CA) and Amy Klobuchar (D.-MN) introduced the CURE High Drug Prices Act. It would give the federal government authority to keep drug companies from raising their prices on some drugs in some instances. Merkley also introduced the Low Drug Prices Act.

    Here’s more from Just Care:

  • Should generic drug labels include off-label uses?

    Should generic drug labels include off-label uses?

    A new bipartisan Senate bill would allow generic drug labels to include off-label uses, Nicholas Florko reports for StatNews. With an FDA finding of sufficient evidence, the bill empowers generic drugmakers to market drugs for particular conditions even though those drugs have not been scientifically proven to treat those particular conditions. It is hard to believe this helps anyone other than the drugmakers.

    Senators Orrin Hatch (R-UT) and Michael Bennett (D-CO) introduced the legislation that would lift marketing restrictions on generic pharmaceutical companies. Today, generic drug companies need approval from the FDA to change a drug’s label. Only then can they market a drug as a treatment for a new condition or a new drug dose. And, that takes time and money.

    Generic drug companies also do not have the right to set in place the process for marketing a drug for off-label use–a different treatment or a different dosage from what was originally intended. Brand-name drug companies only have that right. But, if the brand-name product is pulled from the market, the brand-name drug company that had promoted the drug for a particular use has no incentive to promote the drug for another use. So, the drug labels rarely change.

    The Hatch-Bennett bill would give the FDA authority to review data on generic drugs for off-label use when there is no brand-name competitor. If the FDA finds that there is enough evidence for it to be sold for those uses, the FDA can require a label change. But, the bill is silent as to what evidence would constitute sufficient evidence to require a label change on the generic drug.

    This bill appears to give a lot of power to the FDA and the generic drug makers without adequately protecting individuals. No clinical trials showing the clinical benefits of the off-label use of the drug are required to determine safety issues.  And, doctors can already prescribe drugs for whatever use they please. A label change is not required for doctors to prescribe a drug for off-label use.

    The label change simply expands the drug companies’ ability to market a drug for a new use. Who is really benefiting here?

    Here’s more from Just Care:

  • Pharma’s monopolies are the reason for high drug prices

    Pharma’s monopolies are the reason for high drug prices

    David Blumenthal, President of the Commonwealth Fund, explains in the Fund’s blog, that the simple reason for high drug prices in the US is that Pharma has monopolies over the prescription drug supply for many drugs. This monopoly power results from the patents we grant to pharmaceutical companies for novel medicines.

    Once they are granted patents on their prescription drugs, drugmakers tend to have monopoly pricing power for these drugs for 12 or 13 years. This means that they can charge whatever they would like for their drugs. And, the prices they choose result in industry profits far higher than most other sectors of the economy. For example, in 2015, the 25 biggest software companies had an average profit margin of 13.4 percent; the 25 biggest pharmaceutical companies had an average profit margin about 50 percent higher, 20.1 percent.

    What’s perhaps most insane is that pharmaceutical companies can raise drug prices as they please. There can be some competition from prescription drugs that have their own patents and are marketed to provide the same treatment. But, the competition does not bring down prices sufficiently.

    Moreover, pharmaceutical companies have ways to stretch their monopoly pricing power to as long as 20 years or more. Mylan’s EpiPen patent is just one example. They can change the drug’s packaging or method of administration without clinical benefit and extend their patents. They can also pay off generic drug manufacturers not to bring a generic substitute to market.

    When a patent expires, generic drug manufacturers can enter the market. But, prices often still do not come down because of generic drug company monopolies. For that reason, for example, doxycycline’s price increased 90 times in the two years between 2013 and 2015.

    This drug company monopoly power undermines the free market as a solution for bringing down the price of drugs. We need a “nonmarket force” with as much power as the drug companies to ensure drug prices are affordable. Most foreign governments exercise that power. They do so in different ways. Many base their prices on the clinical benefits of new drugs over other drugs. In all cases, if pharmaceutical companies are not happy with the price of their drugs, they do not have to sell them. But, they usually sell their drugs.

    Drug companies argue that without their ability to generate the revenues they do, they could not develop new therapies. As a country, we need to ask the question how much that innovation is worth and who makes that decision.  For the moment, so long as pharmaceutical companies can set prices for many patented and generic drugs as high as they please, Americans will struggle and those in government with the power to allow negotiated drug prices if they chose to do so will be held accountable.

    If you want Congress to rein in drug prices, please sign this petition.

    Here’s more from Just Care: