Perspectives: FDA Wades Into Pricing Controversy, But Doesn’t Have Authority To Actually Fix It
Read recent commentaries about drug-cost issues.
Is The FDA Digging Its Own Hole On Drug Pricing And Opioids?
The Food and Drug Administration may be digging a huge hole for itself by singling out drug pricing and opioid abuse for priority and focused attention. These two highly-visible and highly-charged issues have been pushed into the political arena. The FDA has, unwisely, agreed to take them on. Both issues are mission impossible for the FDA, which has neither the authority nor the resources to solve either problem. The agency is setting itself up to be perceived as having failed. (Wayne Pines, 5/22)
A Bipartisan Way To Lower Drug Prices
White House budget director Mick Mulvaney has floated an idea to bring down drug prices that's both promising and -- if other Republicans can be persuaded to go along -- bipartisan. At a recent health-care forum, Mulvaney proposed that drugmakers be required to pay rebates to the government on drugs sold to Medicare beneficiaries, as they do with drugs sold to Medicaid patients. ... In an ideal world, the secretary of Health and Human Services would negotiate on behalf of the 41 million people enrolled in Medicare's Part D prescription drug plan. That kind of purchasing power -- accompanied by the right not to cover a drug it deems too expensive -- would give the department great leverage. Unfortunately, Congress not only forbids such negotiation, it requires that Medicare pay for all medicines approved by the Food and Drug Administration. (5/22)
Clinical Trial Participants Should Have A Say In New Drug Pricing
People who volunteer to participate in clinical trials of new drugs provide a valuable service to pharmaceutical companies and to the rest of us. In return, I think that they should have a say in how much these drugs will cost when they hit the market. Not only would that honor their service, but it would also provide a patient-centered mechanism to lower the price of new drugs. (Spencer Phillips Hey, 5/18)
Amgen Can Shrug Off Its Bone-Drug Risks
With promising trial results and an FDA approval seemingly near, Amgen Inc.'s osteoporosis drug Evenity was expected to contribute at least something to the company's top line this year. But Amgen on Sunday evening reported the drug raised unexpected heart-safety concerns. Now the best hope is that its FDA approval will only be pushed to next year and that its commercial opportunity will merely be limited, not eliminated. Otherwise, it may not be worth the effort to keep seeking approval. (Max Nisen, 5/22)
New Taxes Won't Lower Drug Prices
Prescription drug prices continue to be a hot political issue, with the Trump administration preparing to release an action plan as soon as repeal and replace legislation clears Congress. Mick Mulvaney, who heads the White House budget office and is participating in the talks, floated an idea last week that should quickly be crossed off the list of policy ideas. (Grace-Marie Turner, 5/18)
Will PhRMA's New Membership Criteria Help?
Earlier this month, PhRMA — the trade group representing innovator pharmaceutical companies — announced a set of new membership criteria. Going forward, PhRMA members will need to meet certain standards regarding their investment in R&D. PhRMA may have felt it needed to take action to restore public confidence in the industry and to constrain the bad press its members have been receiving on the drug pricing front. In my view, the new rules miss the mark. (Rachel Sachs, 5/22)
Amazon's Long Shadow Falls On Pharmacies
It's hard to think of an industry Amazon.com Inc. isn't currently trying to conquer, or at least thinking of conquering. Pharmacies might be next. According to a CNBC report, Amazon is considering a leap into the prescription-drug business. It wouldn't be easy, but the industry and its investors shouldn't dismiss the threat. (Max Nisen, 5/17)
Pharmaceutical Marketing For Rare Diseases
The US Food and Drug Administration (FDA) draws a distinction between direct-to-consumer advertising of specific drug products, which it regulates, and advertisements intended to create disease awareness, which it does not. Other nations, including the United Kingdom and the Netherlands, that ban direct-to-consumer marketing permit disease awareness efforts. Challenges arise when disease awareness efforts are made for conditions for which only 1 approved drug product is available; in this case, awareness will boost the sales of a specific drug, and several nations, include the United States, selectively regulate this type of advertising. Recently, a novel form of disease awareness promotion, through a daytime soap opera, raised questions about the role and regulation of this form of marketing. (Sham Mailankody and Vinay Prasad, 5/18)
November Ballot Issue Leaves Lower Drug Prices Up To Ohioans
This November, Ohio voters will decide on a referendum that sounds like a sure thing for passage: lower drug prices. No, this isn’t a follow-up to last year’s marijuana measure, which failed anyway. The discount would only apply to drugs purchased by state employees and retirees and through state programs like Medicaid. An estimated 3.7 million Ohioans, close to a third of the state’s population, would directly benefit. (James McNair, 5/22)