Drugs

Public Citizen Rebuffs Draft Pharma Executive Order

“Big Pharma has captured the Trump administration.” That is the bottom line in a Public Citizen analysis of a draft executive order on prescription drug pricing and innovation that president Trump is expected to soon sign. The analysis echoes concern from experts who talked to the New York Times earlier this week (see story).

The draft would do “little other than direct a series of reviews and analyses,” Public Citizen says. “The main aim of that exercise is to identify means to reduce safety standards and expand monopoly protections for the pharmaceutical corporations, failing to reduce costs — and even potentially raising them. The Trump order shifts blame for pharma’s price gouging to federal programs, hospitals and Medicaid, among others — to anything except the pharma corporations themselves. Shamefully, the order even blames developing countries and outlines a plan to intensify the patent abuses that already cost lives and entrench unaffordability around the world.”

The group says the best way to lower prices is to take on the pharmaceutical lobby. It says that instead of the non-measures in the draft order, the Trump administration should:

End monopolies and allow competition. The government should authorize generic competition with monopolized patented medications as a means to reduce costs for public programs.
Block backroom corporate deals that keep medications out of reach. Federal agencies should litigate aggressively to prevent, stop and recoup ill-gotten gains of pay-for-delay deals and prevent anti-competitive mergers and acquisitions.
Crack down on pharma fraud. Federal agencies must crack down on corporate crime, including routine pharma practices to overcharge the states, manipulate safety data and illegally market their products.
Support meaningful legislative reform, including the Medicare negotiation powers Trump has promised, as well as the Stop Price Gouging Act, introduced by U.S. Sens. Sherrod Brown (D-Ohio) and Kirsten Gillibrand (D-N.Y.) and Reps. Mark Pocan (D-Wis.) and Marcy Kaptur (D-Ohio), to stop manufacturers from dramatic increases for medications such as the EpiPen and opioid addiction treatments.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome