Drugs

Patent Abuse Leads to Higher Drug Prices: Column

An opinion column posted online by CNN says that a key source of the problem of high drug costs is abuse of the U.S. patent system. “Healthcare costs could be brought down through greater availability of generic drugs and biosimilars — drugs that are identical to branded drugs but distributed by another company after the original patent expires,” the column says. “Unfortunately, these lower-cost alternatives face an uphill battle to gain market access because pharmaceutical companies employ myriad tactics to prevent competition.”

The authors say that large drug companies have continually engaged in the strategic accumulation of patents to restrict patient access to more affordable drugs by delaying the entry of generic options into the market. “While some of the additional patents represent true incremental innovation, many are deployed strategically to preserve a company’s monopoly rights on the original discovery,” they write. “All in all, the tactics used are not new or useful, they are simply a way for Big Pharma to maintain their drug monopolies and continue charging American consumers more for drugs than they could if they had competition in the market.”

The authors contend that by gaming the patent system to secure monopolies on their products, drug companies are remove the motivation to innovate because they are simply creating new patents that are similar in scope to previously obtained one, thus creating a captured market. This lack of competition has resulted in price increases averaging 68% since 2012 for the top selling drugs in the U.S.

“Patent reform will be a critical element of any real solution to the problem of rising prescription drug prices in the United States,” the post concludes. Streamlining the patent process and strengthening inter partes review as a cost-effective means of challenging bad patents would help to bring generic medications to market and encourage innovations that will benefit patients, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome