It’s Common Knowledge That Many Side Effects Don’t Get Reported To FDA. But Study Reveals Startling Scope Of Problem.
The study found that in one drug only 1% of an estimated 276,000 serious adverse events had been reported. Researchers say they data emphasizes the need for better surveillance of the risk of injury. In other pharmaceutical news: biotechs react to the House drug pricing bill, another drugmaker admits to price fixing, a new medicine might help curb dementia-related delusions, and more.
Stat:
Problems With Medicines May Be Vastly Underreported To The FDA
It’s no secret that the many side effects caused by medicines do not get reported to the Food and Drug Administration, but a new report suggests the magnitude of underreporting is far greater than imagined. After examining side effects that were conveyed to the regulator for five widely used medicines — two different types of arthritis treatments, an antipsychotic, and a blood thinner — just 1% of an estimated 276,000 serious adverse events had been reported in 2017. (Silverman, 12/4)
Stat:
Over 100 Small Biotech CEOs Blast Pelosi's Drug Pricing Bill
Nearly 150 CEOs of emerging biotech companies are sending a unified, stark message to Capitol Hill: Abandon the Democrats’ signature drug pricing policy. In a new letter, signed by buzzy biotech startups like Global Blood Therapeutics (GBT) and Alnylam Pharmaceuticals (ALNY), the executives lob a blistering critique of the signature drug pricing bill unveiled this fall by House Speaker Nancy Pelosi. The legislation would allow Medicare to negotiate the price of certain high cost drugs and wage huge fines for companies that don’t comply. (Florko, 12/5)
Kaiser Health News:
Pharma’s Take On The Pelosi Drug-Pricing Bill: Fair Warning Or Fearmongering?
House Speaker Nancy Pelosi’s flagship proposal to curb prescription drug prices, the “Lower Drug Costs Now Act” ― H.R. 3 ― could come up for a vote in the chamber this month. The measure would allow Medicare to negotiate prices for a limited number of drugs, cap what seniors pay out-of-pocket at $2,000 and force companies that have raised prices beyond inflation since 2016 to either reverse the price or rebate the amount of the increase to the federal government. And drug manufacturers are in full attack mode. (Luthra, 12/5)
Stat:
A Second Generic Drug Maker Admits To Price Fixing In Probe Into Generics
Asmall drug maker called Rising Pharmaceuticals agreed to pay more than $3 million to resolve criminal and civil charges related to a price-fixing scheme involving a high blood pressure pill, the second time a company has reached such a deal with federal authorities who are conducting a probe into the generic industry. From April 2015 until at least September 2015, Rising conspired with another unnamed generic drug maker and its executives to fix prices and allocate customers for Benazepril HCTZ, according to court documents. Effectively, the companies “engaged in a conspiracy to suppress and eliminate competition,” the Department of Justice wrote in a document outlining the charges. (Silverman, 12/4)
The Associated Press:
Drug Can Curb Dementia’s Delusions, Researchers Find
A drug that curbs delusions in Parkinson's patients did the same for people with Alzheimer's disease and other forms of dementia in a study that was stopped early because the benefit seemed clear. If regulators agree, the drug could become the first treatment specifically for dementia-related psychosis and the first new medicine for Alzheimer's in nearly two decades. It targets some of the most troubling symptoms that patients and caregivers face — hallucinations that often lead to anxiety, aggression, and physical and verbal abuse. (Marchione, 12/4)
Bloomberg:
Diabetes Drugs Latest To Be Targeted For Carcinogen Scrutiny
Global health regulators are looking into whether widely used diabetes drugs may contain unsafe levels of a carcinogen that has previously been found in heart and gastric medications. The U.S. Food and Drug Administration said in a statement Wednesday that the agency is testing samples of metformin sold in the U.S. for NDMA, and that it will recommend recalls of the medication as appropriate. Metformin is widely prescribed to patients when they are initially treated for type 2 diabetes. (Lauerman, 12/4)
Politico Pro:
Seade: USMCA Biologics Provision To Be Changed If Deal Reached
A key pharmaceutical provision of the U.S.-Mexico-Canada trade agreement that the Trump administration has hailed as a major improvement over the North American Free Trade Agreement is being modified to make it less onerous for Mexico, a top Mexican official said Wednesday. (Palmer, 12/4)
