As the federal government investigates the role of pharmaceutical distribution companies in a nationwide shortage of generic drugs, Georgians say they are having trouble accessing some critical medicines.
The Federal Trade Commission (FTC) and the U.S. Department of Health and Human Services (HHS) on Feb. 14 announced they are looking into the role group purchasing organizations and drug wholesalers play in contributing to drug shortages, which includes drugs used to treat ADHD, cancer, and rheumatoid arthritis.
In Georgia, doctors and patients say they are waiting longer for drugs or switching to alternatives. Doctors say they are managing the situation – for now – but both they and patient support groups say the situation is untenable, and are urging Congress to find a long-term policy fix.
Susan West Colding of Rome said her stepdaughter had to visit four pharmacies before she could fill a prescription for lisdexamfetamine for her son. “I don’t know why this is happening. Maybe they are trying to make more money by pushing us to a non-generic.”
It’s a trend that Atlanta-area doctors have seen as well.
“As a clinician, I have noticed drug shortages for years,” Joel B. Zivot, Associate Professor in the Department of Anesthesiology at Emory University, told The Atlanta Journal-Constitution. “The drugs that end up being in short supply are the generic drugs.”
Group purchasing organizations (GPOs) were envisioned over four decades ago as a way for hospitals to bulk buy supplies and reduce costs. In 1986, Congress amended the anti-kickback statute to exempt vendor payments to GPOs. But today, just three GPOs and three wholesalers control about 95% of the U.S. pharmaceutical distribution industry. As part of its investigation, the FTC is looking into whether the kickbacks and possible conflicts of interest – like hospital executives sitting on the boards of GPOs – have indeed made drugs both more expensive in some situations, yet more scarce in the case of lower-cost generics.
Melissa Barber, a postdoctoral associate at Yale University, said the reason why the U.S. is experiencing volatility in generic drug supply has been ‘prices are too low.’ The FTC investigation will test this theory.
“I hope that the GPO investigation yields transparency along the supply chain,” Barber told the AJC. “Right now, it is really difficult to ascertain where along the supply chain middlemen are taking a cut, and therefore difficult to target which actors and which incentives.”
In a paper Barber presented in September to a U.S. House subcommittee studying drug shortages, she outlined how drug manufacturers report shortages to the federal FDA, but are not required to explain what has caused the shortage. Some 60% of shortages had no cause given, but for those that did, the majority (72%) were due to increased demand, followed by manufacturing delays or issues (10%).
The issue has made headlines for years. Last year, nine members of the Georgia congressional delegation sent a letter to the FDA seeking answers.
Peter Maybarduk, access to medicine director at Public Citizen, a nonprofit consumer advocacy organization, says the issue of high-cost patented drugs that families struggle to afford, and generic drug shortages, are linked. “In both cases, we think there is too much deference to corporate priorities and not enough oversight and engagement from the government. We applaud the FTC decision to investigate GPOs.”
Maybarduk says California’s public manufacturing proposal, and a plan by Senator Elizabeth Warren of Massachusetts, could help boost supplies of generics. “The government would be in control of the terms of supply. Companies like Pfizer, for example, could complete but they would not be in control of the final price, rather they would meet government established targets.”
The recent shortage of two critical antibiotics illustrates the problem. The FDA added generic amoxicillin to its shortage list. A surge in usage during the recent RSV and flu season put further pressure on supplies. Doctors then switched to non-generic drugs like Pfizer’s penicillin drug, Bicillin. That drug is itself in short supply due to a surge in syphilis infections in the U.S.
Pfizer has increased its Bicillin injectable penicillin production by 30% and plans to double output by the end of 2024, Steve Danehy, Director, Global Media Relations at Pfizer, told the AJC in an emailed statement. “With the significant increased syphilis rate, coupled with the amoxicillin shortages, Pfizer has reprioritized Bicillin L-A production to meet specific patient needs. We are continuing to evaluate additional ways to further increase this production.”
Although the U.S. has been able to import one drug on the shortage list, penicillin, from France until Pfizer can fulfill demand, Europe is also in the midst of its own amoxicillin shortage. Generics makers say pricing pressure in Europe and the U.S. is forcing them to shift production to lower-cost countries like India and China.
In 2022, the U.S. Food and Drug Administration said it was notified about 1,293 potential drug and biological product shortfalls by 150 different manufacturers. Of that number, 49 drugs ended up being in short supply, though the FDA helped prevent 222 potential shortages, according to its annual report to Congress. One recent success was the FDA’s expedited approval in 2022 of a Danish factory that produced the Jynneos vaccine for smallpox and mpox.
A member of Colding’s cancer support group, Melissa Freeman of Rome, said her son has been unable to fill a prescription for ADHD medicine, amphetamine/dextroamphetamine salts sold under the brand name Adderall.
She has been unable to access dronabinol, a medication that helps reduce nausea in patients undergoing cancer treatment. “The symptoms and side effects are as bad, if not worse, than the cancer itself,” Freeman told the AJC. “I am really struggling right now.”
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