This Patent Lawyer May Be Most Powerful Man In Washington When It Comes To Curbing Drug Costs
Newly installed Patent and Trademark Office Director Andrei Iancu holds substantial sway over an intellectual property system that, critics say, has allowed drug makers to extend their monopolies through legal but questionable tactics. In other pharmaceutical news: orphan drugs, FDA regulations, the "Pharma Bro" and more.
Pharma And The Patent System: Will Trump's Appointee Bring Change?
The newly installed director of the Patent and Trademark Office, the soft-spoken Andrei Iancu, could rein in drug makers in more direct fashion than perhaps any other individual in Washington. Unlike the others, he holds substantial sway over an intellectual property system that, critics say, has allowed drug makers to extend their monopolies through legal but questionable tactics — by making slight modifications to products and then filing for new patents, for example, or by working to curtail quicker challenges to their patent in favor of longer, drawn-out litigation in the courts. (Mershon, 3/1)
Drug Makers Are Seeking More Orphan Designations Than Ever Before
Orphan drugs may target small patient populations, but they continue to rack up big numbers at the Food and Drug Administration. Last year, the agency issued a record-breaking 77 orphan drug approvals, far exceeding the previous annual high of 49 approvals notched in 2014. At the same time, the FDA agreed to award a stunning 476 orphan designations, well above the 355 designations made in 2015, which was the previous record total. And there were 526 designation requests last year, second only to the record of 582 made in 2016. (Silverman, 2/28)
Under Trump, The Pace Of FDA Regulations Slowed To A Trickle
As the Trump administration settled in last year, the White House insisted on fewer regulations — and the Food and Drug Administration delivered, according to a new analysis. Last year, regulatory actions taken by the agency were only a fraction of the number of actions taken during the Obama administration and in fact dropped to the lowest level of any time in the past 20 years, according to the Health Research Institute at PricewaterhouseCoopers, the consulting firm. (Silverman, 2/28)
The Associated Press:
‘Pharma Bro’ Asks Judge For Leniency, Saying He Was A Fool
“Pharma Bro” Martin Shkreli admitted that he was “very far from blameless” in a letter to a judge asking for leniency, according to court filings. “I was wrong, I was a fool. I should have known better,” Shkreli wrote in his letter to Brooklyn federal court Judge Kiyo Matsumoto. “I accept the fact that I made serious mistakes, but I still believe that I am a good person with much potential,” Shkreli said. (2/28)
Doctor Admits Disclosing Patient Info To Drugmaker Aegerion
A Georgia pediatric cardiologist pleaded guilty on Wednesday to wrongfully disclosing information about his young patients to an Aegerion Pharmaceuticals Inc sales representative seeking to identify potential new users of an expensive cholesterol drug. Dr. Eduardo Montana, 55, entered his plea in federal court in Boston after Aegerion, a unit of Novelion Therapeutics Inc, agreed in September to pay $40.1 million to resolve U.S. investigations related to its marketing of the drug, Juxtapid. (Raymond, 2/28)
Is Celgene The Biotech That Couldn't Shoot Straight?
In a stunning setback for Celgene (CELG), the Food and Drug Administration has refused to review a drug that the biotech has been testing for multiple sclerosis because of “incomplete” pharmacology data. The move is deeply significant: Not only is the medicine the most important product in the Celgene pipeline, but the refusal is the latest in a series of shocks that has unnerved investors over the past few months. Just last month, for instance, Celgene executives signaled that FDA approval for the drug, called orzanimod, was expected by the end of this year. Last October, the company unexpectedly halted development of another drug for combating Crohn’s disease, and then shortly afterward made deep cuts to its long-term financial guidance, moves that sent its shares plunging. (Silverman, 2/28)