Prashant Kumar

It has been a few years since the infamous Martin Shkreli was in the news. And we have another opportunity to thank him for exposing (unintentionally, of course!) some of the worst secret practices of the drug industry. This time Mr. Shkreli shows how companies can use non-disclosure agreements and exclusivity contracts to artificially keep … Read more

A Federal judge in California ruled that FDA’s interpretation of its own Guidance Documents regarding autologous cell therapy is faulty and hence subject to legal challenge. Specifically, the judge ripped through FDA interpretation of the “same surgical process” exemption for the regulation of Human Cellular and Tissue-based Products (HCT/P). The case in point was a … Read more

The law requiring sponsors of clinical trials to post results from their trials to the clinicaltrials.gov website is almost 13 years old but many sponsors don’t care to comply and  the government agencies responsible to enforce this law, NIH and FDA, have no plans to compel the sponsors to do so. Ironically, many trials with … Read more

The patients and doctors expect FDA to approve products based only on credible scientific data, but a few cases have shown that FDA does not always do that. In those cases, it falls on patients and their doctors to make sensible decisions based on facts before embarking on uncertain therapies carrying astronomical price tags.  FDA … Read more

A couple of months back, there was a lot of hoopla when it became public that Google made a deal with one hospital chain to access personal medical data of millions of patients without patients’ consent. It seems that was but a tip of the iceberg. This week the Wall Street Journal reports that Google … Read more

FDA is approving new drugs and medical devices too fast, its reviewers are leaving for jobs in the industry they regulate, and it is critically short on resources, the editors of the New York Times opined this week. Another article this week in the Journal of American Medical Association (JAMA) by Harvard researchers, raised similar … Read more

The high cost of healthcare in the US is often blamed on the high cost of prescription drugs, however, a recent study showed that the administrative costs play a much bigger role in our increased medical bills. The US healthcare costs is often compared to that in Canada, with laws being created to reimport drugs … Read more

For the last few years FDA has been approving more than 40 new drugs each year, a trend that continued in 2019 with the approval of 48 new drugs and biologics. But it is important to look beyond the numbers to fully understand the trend behind these. First let’s look at the numbers. This year’s … Read more

About 1200 currently ongoing clinical trials in the US are using digitally connected tools such as wearable devices and mobile apps. That’s a 6-fold increase from about 200 such trials in 2009. However, with about 22,000 studies ongoing in the US, this is a small fraction of all clinical trials. There are several obvious benefits … Read more

The GAO reports this week that FDA is severely short of inspectors capable of auditing foreign sites, it gives up to 12 weeks’ notice to foreign sites prior to inspections giving them ample opportunity to clean-up and cover deficiencies, and its inspectors for foreign sites are given inadequate time to complete their job making them … Read more