Generic drug substitution laws vary greatly across US
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State laws regarding generic drug and interchangeable biologic substitutions vary widely in the United States, researchers reported.
Generic drugs saved the U.S. health care system $1.7 trillion between 2007 and 2016, and biologics currently account for 2% of dispensed medications and almost 40% of spending, according to researchers.
Past research has linked generic drugs with improved medication adherence and health outcomes, Chana A. Sacks, MD, member of a regulation, therapeutics and law program in the department of medicine at Brigham and Women’s Hospital, and colleagues wrote. They added that more consistency in substitution laws across states could “reduce health system spending [and] improve population health.”
Sacks and colleagues examined state laws regarding generic drug substitution in all 50 states and the District of Columbia as of Sept. 1, 2019. Findings showed that:
- 7 states and the district needed patient consent before switching to a generic.
- 19 states required pharmacists to perform generic substitution for small-molecule drugs.
- 24 states did not specifically protect pharmacists from greater liability when substituting the generic.
- 32 states and the district required patient notification regardless of the drug’s packaging.
“Our findings highlight considerable room for optimizing state drug product selection laws to promote generic and interchangeable biologic substitution,” Sacks and colleagues wrote.
The findings should be alarming to the medical community, added Ameet Sarpatwari, PhD, JD, member of a regulation, therapeutics and law program in the department of medicine at Brigham and Women’s Hospital.
“Physicians should be concerned over this variation because it reveals that policies are lacking to ensure optimal use of generic drugs, the use of which has been associated with improved medication adherence and health outcomes,” he told Healio Primary Care.
In an invited commentary, Francis J. Crosson, MD, senior lecturer of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine in Pasadena, California, encouraged the removal of "poorly designed state regulations that inhibit the use of generic drugs, while at the same time ensuring that treating physicians are aware of what formulations their patients are actually receiving.”
Crosson, also a member of JAMA Internal Medicine's editorial board, added that the rising costs of many prescription drugs are contributing to increasing Medicare Part B and D expenditures. However, after the COVID-19 pandemic subsides, those programs will be expected to cut costs. Therefore, “efforts to ensure that unnecessary expenditures for drugs are mitigated must continue unabated,” he wrote.
References:
- Crosson FJ. JAMA Intern Med. 2020;doi:10.1001/jamainternmed.2020.3593.
- Sacks CA, et al. JAMA Intern Med. 2020;doi:10.1001/jamainternmed.2020.3588.
Perspective
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C. Michael White, PharmD, FACP, FCCP
Generics are a wonderful and cost-effective option for patients. We should promote the use of generics as a cost-effective way to lower drug spending since it has delivered tremendous cost effectiveness. However, like the man who slayed the Golden Goose, at the expense of United States-based manufacturers and patient safety, we did not cultivate the generic marketplace correctly.
As I wrote in an Annals of Pharmacotherapy editorial last year, the lowest price generic drug, regardless of product or manufacturer quality, is a major issue in the U.S. at this time. The FDA has shown it lacks the ability to do the same rigorous inspections overseas that it does in the U.S. and cannot perform unannounced inspections except in the rarest of circumstances. When the FDA started stepping up such inspections, they found egregious practices in numerous facilities including outright fraud.
In the current reimbursement paradigm, pharmacists would lose their shirts if they used a generic manufacturer that was slightly more costly but had a stronger track record of delivering high quality with excess capacity to prevent drug shortages. This is penny wise and pound foolish. The FDA has recognized this issue and is starting to float the idea of paying for drug quality, but many hurdles remain.
Forcing the lowest possible price has caused massive consolidation in the generic marketplace, and it is well known that the fewer the number of manufacturers of a generic drug, the higher the price is paid for medication over the long term, even without growing price gouging and the greater propensity of drug shortages. I co-authored a 2012 paper in the British Journal of Pharmacology that looked at epilepsy medications. We showed that while generics and brand name drugs work similarly, the switch from a brand to a generic or between two generics can cause clinical instability resulting in greater health care utilization during that transition. Given the state of that disease, alerting the patient when the manufacturer is going to change is clinically reasonable. I do not fault states that put in that exception, such as here in Connecticut.
If the FDA could guarantee that the brand and generic products were truly interchangeable in all disease states, then attempts to allow patient and prescriber notification or right of refusal would be wholly celebrated. Unfortunately, that is not the current reality that we are living in.
References:
Talatia RT, et al. Pharmacotherapy. 2020;doi:10.1002/j.1875-9114.2012.01099.x.
White CM. Ann Pharmacother. 2019;doi:10.1177/1060028019881692.
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