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pharmaceuticals
Contract Pharmacies Help 340B Patients; Drug Companies Are Restricting Them
Since 2020, 21 drug companies have restricted the number of contract pharmacies where 340B nonprofits can fill patient prescriptions. Their attack undermines the intent of the 340B statute.
May 05, 2023
Drugcompanies keep making excuses for why they do not have to live up to their 340B statutory obligations. Since 2020, 21 drug companies have restricted the number of contract pharmacies where 340B nonprofits can fill patient prescriptions. Their attack undermines the intent of the 340B statute.
Drug companies insist they have legitimate oversight concerns, yet their supposed good governance concerns belie the pharmaceutical industry’s true intent. Simply stated, drug makers want to extract every dollar they can from their products, even if it means breaking an agreement with the federal government to sell a tiny percentage of their drugs at a discount to the nonprofits that reinforce America’s healthcare safety net.
Healthcare nonprofits rely on 340B drug discount savings to care for the most vulnerable Americans. For patients to access life-saving medicines, they must be able to pick up their prescriptions from community pharmacies. Many low-income, uninsured Americans lack the time and resources to travel far from their work and homes—often passing by multiple pharmacies—to a single drug company-approved prescription drug dispensing site. The 2010 Affordable Care Act (ACA) recognized that problem, empowering the Health Resources and Services Administration (HRSA) to promote medication access through contract pharmacy use. Federal guidelines wisely allow nonprofits to engage in multiple contract pharmacy agreements.
Simply stated, drug makers want to extract every dollar they can from their products, even if it means breaking an agreement with the federal government to sell a tiny percentage of their drugs at a discount to the nonprofits that reinforce America’s healthcare safety net.
So why did drug companies wait until 2020—10 years after the HRSA guidelines went into effect—to begin enacting contract pharmacy restrictions? The answer is simple. Just one year earlier, in 2019, a little-known ACA provision which requires drug makers to submit drug pricing information to a database finally came online. The “ceiling price” database provides nonprofits with the requisite data to ensure drug companies do not charge above the 340B ceiling price. Companies that overcharge are subject to a civil monetary penalty. The 340B statute requires those companies to then sell the offending drug at just one penny in the next calendar quarter.
Data transparency shows that drug companies have broken the law, frequently overcharging healthcare nonprofits for prescription drugs. The pre- and post-ceiling price data reveal a stark contrast in how often HRSA uncovered drug company malfeasance. From 2015 to 2018, only 6% of HRSA audits uncovered instances of drug company overcharging. After January 1, 2019—when mandatory drug company database reporting began—audits found overcharging in 67% of cases. In 2021 alone, 80% of audits revealed drug company overcharges.
Take Eli Lilly as just one example. In December 2022, the drug maker announced refunds for 340B overcharges for the fifth time that year. It is no coincidence that restrictions began apace with the advent of the ceiling price database.
Essentially, drug companies had no issue with nonprofits using multiple contract pharmacies when they could get away with rampant overcharging. And why would they? Without the government watching, multiple dispensing sites afforded drug companies more opportunities to overcharge nonprofits. Drug companies got away with nearly a decade of overcharges, with no recourse for nonprofits. Now, the same companies that ran wild when the government was not watching, decry the lack of federal oversight when it comes to nonprofit contract pharmacy use.
For the record, 340B nonprofits are subject to audit by the federal government and drug makers. Failure to comply removes a nonprofit provider from the 340B program.
Contract pharmacy restrictions couched as best practices represent a cynical ploy by drug companies. Drug companies caterwaul that oversight lapses result in double-charges for 340B discounts, once by nonprofits and once by state Medicaid agencies.
Simply saying something does not make it true. HRSA conducted 638 hospital audits since 2018 to ensure Medicaid fee-for-service compliance rules, and not one 340B contract pharmacy duplicate discount occurred. Drug companies want to be able to raise list prices year-over-year without 340B statutory penalties, and, now that a federal agency is watching, program obligations threaten the bottom line. Drug makers now consider 340B discounts as financial exposure to be avoided at all costs.
Ignore drug industry duplicity when it comes to 340B. Drug companies have repeatedly acted in bad faith, finding any loophole possible to abrogate statutory obligations.
If drug companies no longer wish to participate in 340B, they can leave the program and no longer sell their products to Medicaid and Medicare. Perhaps that is a deal they can finally honor.
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Big Pharma Using India's Poor as 'Lab Rats' to Test Meds
Multinationals outsource testing, unbeknownst to Indian patients
Jul 11, 2013
Multinational pharmaceutical companies are treating patients in India like "lab rats," distributing untested drugs for research purposes without the patients' informed consent,Agency France-Presse highlighted on Thursday in a report pulling from personal accounts.
The issue is ongoing and widespread and has been subject to a Supreme Court Case in India -- which led Supreme Court judges R.M. Lodha and A.S. Dave to state, "There has to be some sense of responsibility. Human beings are treated like guinea pigs."
Pharmaceutical companies often go to India where the rules are less strict and the testing procedures subsequently far less costly.
"In Europe and the United States the laws are pretty strict. India, on the other hand, makes for a less restrictive destination for drug trials because the regulator lacks teeth," said health campaigner Amulya Nidhi, who works for the Swasthya Adhikaar Manch group, which is fighting on behalf of many of the pharmaceutical trial victims.
As a result, "many desperate and poor people in India are unwittingly taking part in clinical trials for drugs by Indian and multinational pharmaceutical companies that outsource the work to unregulated research organizations," AFP reports.
Such was the case with Niranjan Lal Pathak, the center of the AFP article, who was offered free treatment for a heart complaint at his local hospital. The medicine, unbeknownst to him, turned out to be an untested drug called Atopaxar, developed by Japan-based pharmaceutical company Eisai for anxiety disorders. Pathak was the victim of a drug trial without his informed consent.
His family says that Pathak is now suffering from extreme dementia--a side effect of the drug.
"He barely recognizes us. His life is finished and so are our hopes to see him healthy and happy again," a family member told AFP.
"The label on the medicines often does not specify that it is meant for trial, and vulnerable people end up being used as lab rats," said Nidhi.
The problem is rampant, according to AFP, while India's lawmakers are currently mulling over amendments to the Drugs and Cosmetics Act that would place the responsibility on companies that are supposed to oversee the trials. However, no time-frame has been given to pass the act.
Recent reporting by The Times of India showed that up to 2,600 "human guinea pigs" have died in the past seven years during drug trials by foreign pharmaceutical corporations.
According to the paper, trials of 475 drugs took place during that time but only 17 of them were actually approved for marketing in India.
Clinical trials of two drugs--Bayer's Rivaroxaban and Novartis's Aliskiren vs. Enalapril--accounted for the most deaths and were repeatedly used despite widespread fatalities.
In 2011, Al Jazeeradocumented this growing trend over the last decade, showing US pharmaceutical companies who have moved their testing operations overseas to cut costs. The "costs," however, are externalized on low-income patients around the world--with deadly results. Watch below:
Outsourced: Clinical trials overseas | Fault LinesUS pharmaceutical firms have moved their operations overseas over the past decade. An increasing number of tests are being ...
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