Skip to main content

See also:

New diabetes drug approved by FDA despite incomplete testing

The eMPR web site announced the release of a new oral drug for diabetes that has been shown to lower A1c versus a placebo. The release was announced on August 1, 2014 with a title of New Oral Diabetes Approved. The new drug is called Jardiance (empagliflozin) and blocks the reabsorption of glucose in the kidneys. It is manufactured by Lilly/Boehringer Ingelheim.

Despite known heart risks, FDA allows drug to remain on market
Despite known heart risks, FDA allows drug to remain on marketPhoto by Joe Raedle/Getty Images

When the issue of the cost of a new drug occurs, the pharmaceutical manufacturers cite the cost of the drug trials. Jardiance was tested on 4,480 patients with type 2 diabetes in a total of seven trials. It showed an improved hemoglobin A1c level when compared to a placebo. Jardiance is approved as a single drug treatment for diabetics, and can be used with other existing diabetic drugs that include insulin, metformin, sulfonylureas, and pioglitazone.

The FDA approved Jardiance with a requirement that additional testing be done after the drug has been released to market. The areas that have not been fully researched are significant.

The FDA is requiring the following four postmarketing studies for Jardiance: completion of an ongoing cardiovascular outcomes trial, a pediatric pharmacokinetic/pharmacodynamic study, a pediatric safety and efficacy study, and a nonclinical juvenile toxicity study with a focus on renal development, bone development, and growth.

The FDA is releasing new drugs without assuring the safety and effectiveness of these drugs in critical areas. The FDA is allowing an approach of letting the severity of adverse effects be identified within the outcomes on the patients. The “postmarketing” testing should be “premarketing” testing.

In a testing on 4,480 patients, approximately 50% of the subjects were given a placebo. This means that the safety of Jardiance was determined by the effects seen on approximately 2,440 patients. This is not an exhaustive study, and the postmarketing requirements point to known areas of concern by the FDA. Since Jardiance was already released in Europe, the prescribing information provides information on key areas of concern that have been identified. The FDA should have required safety information in these areas before approval instead of relying on postmarketing testing and adverse effects reports.

At the core of the issues of the FDA approval process for new drugs, there are several key factors:

  1. The top administrators in the FDA are often former executives in the pharmaceutical companies.
  2. The top lobbyists for the pharmaceutical companies are often former executives and former employees of the FDA.
  3. The FDA is allowing pharmaceutical companies to defer key safety and efficacy studies for new drugs until after the drug has been released to the market.
  4. The FDA is allowing companies to advertise new drugs directly to the public while minimizing adverse effects that cause major health issues in a significant number of patients.
  5. The adverse effects of new drugs are not published by the FDA to the general public if “postmarketing” studies indicate a major problem. These problems are publicized by lawyers advertising class action suits on television and in print advertisements by the lawyers.

The resubmission of Jardiance for approval as a New Drug Application (NDA) was done on June 18, 2014 by Lilly/Boehringer Ingelheim. Jardinace was approved on August 1, 2014. Whatever the FDA’s prior issues for Jardiance to require a new submission, the issues were resolved in less than six weeks.

The press release announcing the approval of Jardiance is available. The announcement of the New Drug Application by Lilly/Boehringer Ingelheim on June 1, 2014 is also available.

Jardiance was approved in Europe before the FDA approved it in the US. The prescribing information is available for advice to doctors in the UK. It indicates that the issues identified in the “postmarketing” studies required by the FDA have already been identified in European patients.

The structure of the FDA and the relationships between the pharmaceutical manufacturers and the FDA approval structure needs to be changed to provide an arms-length approach that does not gloss over major safety and efficacy issues in new drugs.

New drugs approved by the FDA need to proven safe and effective before they are offered to the marketplace.