Medicinal drugs in the U.S. The aim was to examine the effects of switching brands. Reuters reports that Merck Sharp and Dohme (MSD), a foreign unit of Merck, recently won an injunction against India-based Aprica Pharmaceuticals, which had planned to begin manufacturing generic versions of two diabetes drugs originally developed by Merck. Not all generic drugs increased in price. Every drug that has been developed by the original company has patent protection, which lasts for a variable amount of time, depending on the molecule. Can you imagine the savings when generics amount to, say, 35% of the dollar share? In these 3-tier plans, all generic drugs were de facto “preferred.” Now, however, a number of insurers have split their all-generics tier into a bottom tier consisting of “preferred” generics, and a second tier consisting of “non-preferred” generics, paralleling the similar split that one typically finds with branded products.
This news, however, was mostly a boon to people with type 2 diabetes who could now take low-cost versions of blood pressure meds, ACE inhibitors, sulfonylureas and—perhaps the most popular and effective type 2 drug of them all—metformin. “Insulin is an inconvenient medicine even for people who can afford it,” says Riggs, a research fellow in general internal medicine and the Berman Institute of Bioethics at Johns Hopkins. “This decision will go down well in the U.S. On current analogue insulins (Humalog, Novolog and the like), patents won’t expire until 2013 and 2015. They believe the underuse of generic drugs is likely fueled by patient concerns about their safety and efficacy, with many believing that because they are cheaper, they will be less effective. All enrollees under the age of 65 years who had at least 4 contiguous quarters of enrollment in 2005 through 2008 were selected. The prices of older cancer drugs also rose, including for example, the price of Gleevec, which is used to treat adults with leukemia.
The second is to make sure they’re able to breathe freely when lying down without having to use a pillow to elevate their head. Typically, new prescription drugs are available only from the company that developed and patented them for the first few years after gaining FDA approval. Generic Micronase is an oral antidiabetic medicine used to treat type 2 diabetes (non-insulin-dependent diabetes), the kind that occurs when the body either does not make enough insulin or fails to use insulin properly. Chain and big-box drugstores offer discount generic drug programs, some of which may require buyers to become a member. 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. Those who exclusively formula-fed their babies at 6 to 9 weeks of age were more than twice as likely to develop diabetes as women who exclusively breastfed their infants.
Silver and Benjamin A. 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? 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. 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. Thus, we should not expect massive price reductions: a biosimilar manufacturer might for example choose to come in at ~20% below the going rate, sufficient to motivate change whilst ensuring a healthy profit. Either way, the super-high prices can’t last too long. (Hemoglobin A1c measures your average blood sugar over time.) Prevents the harmful effects of high sugar levels on your organs and blood vessels. Eventually, it can progress to blindness. 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. “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…. 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. Filer looks up pricing information and prints out coupons to give to patients when available.
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.