USFDA

In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients.

The U.S. Food and Drug Administration  permitted marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin under the skin for children and adults with diabetes. This new type of insulin pump, referred to as an alternate controller enabled (ACE) infusion pump, or ACE insulin pump, is the first interoperable pump, meaning it can be used with different components that make up diabetes therapy systems, allowing patients to tailor their diabetes management to their individual device preferences. Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.

U.S. Food and Drug Administration issued a warning letter to Mark Berman, M.D., of Beverly Hills, California, for illegally marketing an unapproved implantable device, the Pocket Protector, that Dr. Berman claims can prevent and treat a complication of breast implants known as capsular contracture, or tightening of scar tissue. The warning letter also notifies Dr. Berman of significant deviations from the FDA’s quality system requirements and current good manufacturing practices (CGMPs), including deviations from manufacturing processes intended to keep implants sterile.

The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA.

On the illicit drugs front, worked to increase our enforcement and interdiction work targeting illegal, unapproved, counterfeit and potentially dangerous products being shipped illegally through international mail facilities (IMFs). Tens of millions of packages are estimated to contain FDA-regulated products, and a surprisingly high percentage of these products are illegal. In fact, in recent years, 86 percent of the packages that were suspected of containing FDA-regulated products and were pulled for FDA review indeed contained illegal, illicit, unapproved, counterfeit and/or potentially dangerous drugs.

The U.S. Food and Drug Administration is warning patients and doctors, who use at-home or in-the-office medical devices to monitor levels of the blood thinner warfarin, that certain test strips used with the devices may provide inaccurate results and should not be relied upon to adjust the drug dosage. Medical product distributor Terrific Care/Medex Supply LLC issued a voluntary recall of certain Roche Diagnostics test strip lots used with CoaguChek test meter devices last month. The FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death. This recall is related to the November 2018 Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips.

Nicox SA an international ophthalmology company, announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company's Investigational New Drug (IND) application for NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis.  The IND was submitted to the U.S. FDA in December 2018 ahead of the target of the first quarter of 2019.

The U.S. Food and Drug Administration permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women.

The  number of overdose deaths involving prescription and illicit opioids more than doubling over the last seven years to nearly 48,000 in 2017.  This includes new ways to increase availability of naloxone, a drug used to treat opioid overdose.

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments.

Digital technologies create new opportunities to transform health care and empower patients to make better informed decisions about their health. Digital tools are rapidly evolving, and to keep pace with this promising innovation, the FDA must modernize its approach to regulation.