A key organization says that doctors should write more prescriptions for generic drugs to hold down the high cost of medicines. That sounds reasonable. Why might this recommendation be problematic?
We are pleased to read in the Annals of Internal Medicine (online, Nov. 24, 1015) that the American College of Physicians (ACP) is paying attention to the skyrocketing cost of prescription drugs. The organization points out that we are now spending $324 billion each year on such medicines. The ACP urges its members to prescribe generic substitutes whenever possible.
The president of this organization states that “clinicians often prescribe more expensive brand-name drugs when equally effective, well-proven, and less-expensive generic versions are available.”
The group commissioned a study to see how often generic and brand-name drugs are prescribed. The patient population in the study had diabetes and was on Medicare. Between 23 and 45 percent of the prescriptions were written for brand-name medicines, even though generic versions were available. The doctor group suggests that writing prescriptions for generic drugs could help patients afford their medicines. This should make it easier for them to take their medications more consistently.
What The American College of Physicians Has Missed:
This seems like good sense and we would normally applaud the recommendations of the ACP to encourage doctors to prescribe generic drugs whenever possible. Sadly, there are some problems with this approach.
The American College of Physicians has not addressed pharmaceutical industry greed. Many of the greatest price increases seen in recent years are for new cancer drugs that are game changers for desperate patients. It is not unusual for such drugs to cost $10,000 to $15,000 per month. There are no generic substitutes for these new medications.
Important advances for treating hepatitis C can cost around $100,000 per patient. And an important new cystic fibrosis medicine can reach $259,150 per patient per year. There is no generic substitute for this medicine (Orkambi). Why isn’t the ACP tackling the issue of exorbitant pricing for orphan drugs? And by the way, some generic drugs are also skyrocketing in price (see this article for proof). Why hasn’t the ACP acknowledged this problem and argued for an end to this price gouging?
The Problem with Generic Drug Substitution:
The American College of Physicians asserts that generic drugs are just as effective as their brand name equivalents. The ACP acknowledges that there were problems with the generic antidepressant bupropion (Wellbutrin):
“…after the loss of patent protection for bupropion (Wellbutrin [GlaxoSmithKline]), dozens of spontaneous reports were submitted to the U.S. Food and Drug Administration describing a loss of antidepressant effect or new or worsening adverse effects among patients who had switched from the brand-name to the generic version of this agent. Several generic versions of bupropion were found not to be bioequivalent to the brand-name version.”
That is a gross understatement. Our website alone accounted for hundreds of reports of problems with generic bupropion (see this link). We transmitted way more than dozens of these reports to the FDA.
What About Generic Drug Manufacturing Quality?
Perhaps even more alarming than the bupropion debacle is the problem of foreign manufacture. The FDA has itself admitted that it has not had enough inspectors on the ground in countries like India and China where so many generic drugs are now made. The ACP has not acknowledged the problems with foreign-made generic drugs and the historic inability of the FDA to monitor clinical testing and manufacturing abroad.
This summer the European Union suspended the sale of 700 generic drug formulations from India. The reason was that the company responsible for testing the generic drugs in subjects in India violated standard procedures. The U.S. FDA has not identified drugs that it approved based on data generated by that company (GVK Biosciences).
Equally disturbing is a Reuters report noting that the FDA has barred 44 manufacturing plants in India from exporting their medications to the U.S. since 2011. Some of the companies involved include Aurobindo, Polydrug, Ranbaxy, Sun Pharmaceutical and Wockhardt. Check your medicine cabinet and you are likely to find a generic drug with one of those names.
Dr. Reddy and the FDA:
One of the largest Indian generic manufacturers is Dr. Reddy. Last summer the FDA required Dr. Reddy’s Laboratories to recall certain lots of the anti-seizure drug divalproex, the blood pressure pill amlodipine and the cholesterol-lowering medicine atorvastatin. On November 5, 2015, the FDA sent a Warning Letter to Dr. Reddy’s Laboratories. In that communication the FDA noted:
• significant “deviations and violations” during inspections at three pharmaceutical manufacturing facilities in India.
• There were missing entries and samples that were re-tested following failing results “until acceptable results were obtained.”
• There were “13 instances of out of specification results for a single impurity…”
• There were “manual interventions” that posed risks of “compromising sterility of the product.”
“Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and your firm’s quality control unit did not review and approve those procedures, including any changes….
“Several violations are recurrent or represent long-standing failures to adequately resolve significant manufacturing quality problems. It is apparent that you have not implemented a robust quality system at your sites.”
The People’s Pharmacy Bottom Line on Generic Drug Savings:
We wish we had the same confidence in the quality of foreign-made generic drugs that the American College of Physicians seems to have. When the FDA itself uncovers such serious problems at major generic manufacturing facilities, we would think the ACP would take note.
We all want affordable, high-quality generic medicines. Here are our recommendations. We would like the ACP to adopt our suggestions and encourage Congress to pass legislation that would force the FDA to abide by these rules:
- Country of origin of the active pharmaceutical ingredient (API) must be on the generic drug label. Why shouldn’t drug labels be as transparent as those on T-shirts or apples?
- The FDA must release bioequivalence data for its generic drug approvals. The only way physicians, pharmacists and patients can trust the FDA’s generic drug decisions is to see the data and the bioequivalence curves. Time for transparency!
- Random analysis of generic drugs for quality and performance, including dissolution properties, should become routine. Products should be sampled from pharmacy shelves across the country on a regular basis.
- Authorized generic drugs made to the exact same specification as the original brand name drugs in every detail exist; consumers should be made aware which generic drugs are authorized generics and what company makes them.
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