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In the conclusion of her recently published book, “Bottle of Lies,” Katherine Eban briefly notes that the Food and Drug Administration avoids sanctioning generic manufacturers that sell drugs that are in short supply regardless of how poorly manufactured or counterfeit they are. “Drug shortages had become a game,” she writes, “and the FDA was getting played.” Eban quotes an assessment by former FDA inspector Peter Baker: “There are no consequences for companies that are shipping substandard product. … It’s a win-lose situation and [patients] are the losers.” (David Introcaso and Zack Szlezinger, 8/9)

Drugs could still be marketed to medical professionals, but a waiting period on advertising to consumers would help us avoid wasting lots of money on drugs that turn out to have marginal incremental value, such as rosiglitazone (Avandia) for diabetes, and carry unknown risk, such as rofecoxib (Vioxx) for arthritis. (Jeffrey M. Drazen, 8/13)

When the federal government recently announced that it will allow pilot projects in a few states whereby wholesalers and pharmacists could import drugs from Canada, not all the details were apparent. It will be many years before the average American will be able to import any drug at all. And,  it is likely that after completion of the lawsuits and the pilot projects, drug prices in Canada will rise, meaning Americans would not see lower costs.  In addition, the pilot projects exclude the most expensive prescription drugs, called biological drugs.There is a quicker and better way to achieve the same goal: Eliminate consumer use of prescription drug coupons.  Prescription drug coupons immediately save consumers money on their prescription drug out-of-pocket expenses but this conceals a dark underside that costs billions of dollars on the back end. The federal government bans prescription coupons for Medicare or Medicaid because it believes that they are illegal kickbacks that violate federal law, but inexplicably allows them for patients with commercial insurance. (C. Michael White, 8/8/19)

The Food and Drug Administration recently approved a single-dose gene therapy, Zolgensma, that has the potential to cure spinal muscular atrophy. That was cause for hope for the hundreds of patients suffering from it, along with their families and physicians — until its manufacturer, Novartis, announced the treatment’s price tag: about $2.1 million per patient.That’s believed to be more than any one medication has ever cost. (8/13)

Under the famous agreement that George W. Bush made to fund Medicare Part D more than a decade ago, Medicare was barred from negotiating drug prices. This was done because Medicare all by itself is the biggest buyer of drugs in the world, and it would be able to essentially dictate the price of prescription drugs. Drug makers have threatened in response that they’ll refuse to sell drugs to Medicare if they can’t negotiate a fair price for them. The ability to refuse to sell, just like to right to refuse to buy, is a key component of negotiation. (8/11)

Given the great partisan divide, can we encourage our senators, and all members of Congress, to find a couple of issues to rally around? Issues that matter to Americans. While everyone is talking about gun issues and whether Washington can do anything about it this time, there’s another obvious issue that merits action. The escalating cost of prescription drugs — a topic of two columns on this page last Thursday — already is gaining some bipartisan support in Washington. And for good reason. (8/12)

Congress needs to stop prescription greed. Here in Pennsylvania, the average annual cost of brand-name prescription drug treatment went up 58% between 2012 and 2017, while the income for state residents increased only 10%. Prescription drugs don’t work if patients can’t afford them. That’s why the U.S. Senate needs to pass the Prescription Drug Pricing Reduction Act when lawmakers return from the August recess. The bill would limit out-of-pocket costs for seniors and target drug companies when price hikes outpace inflation. Help can’t come soon enough — the average drug price increased 10.5% during the first six months of 2019. That’s five times the rate of inflation. (Joanne Corte Grossi, 8/12)