Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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The "Safety Argument" Against Making It Legal to Import Rx Drugs is a "Cop Out"

The "Safety Argument" Against Making It Legal to Import Rx Drugs is a "Cop Out" | Pharmaguy's Insights Into Drug Industry News |

Consider this: Sixty percent of Americans say lower drug costs should be a top priority, and a whopping 72 percent support the idea of importing medicines from Canada, according to a recent Kaiser Family Foundation poll. In fact, 8 percent of adults surveyed reported that they or someone in their household have already bought prescription drugs from outside the U.S.


Meanwhile, the cost of 20 widely used drugs is three times cheaper in Canadian than in New York pharmacies, according to, a website that vets overseas pharmacies and compares prices. And as drug makers regularly hike prices — sometimes to sky-high levels — or set steep price tags for the newest treatments, more American pocketbooks are pinched than ever before.


“The problem is getting worse,” said Rep. Peter Welch, a Vermont Democrat who last week unsuccessfully attempted to stick an importation amendment onto a regulatory bill.


Yet from the time nearly two decades ago when seniors made headlines by taking buses to Canada to stock up, the pharmaceutical industry has stymied every attempt to allow Americans to import medicines (read, for example, “PhRMA Lobbying Pays Off Again: Senate Panel Rejects Proposal to Allow Importation of Rx Drugs from Canada”). Drug makers have succeeded by exploiting fears over safety concerns. They’ve also lavished political contributions on members of Congress.


Can importing drugs bring down prescription prices for Americans? Yes and no

The latest example of pharma pushing back against importation came in the form of a report released this month by former FBI director Louis Freeh, who was once a Bristol-Myers Squibb board member and now runs a consulting firm. His sobering conclusion: Importation would increase the threat of counterfeit medicines into the U.S.


“The burden of enforcement will fall on American authorities and the resources for this are really minimal,” said Freeh, whose firm was commissioned by the Partnership for Safe Medicines, a nonprofit with ties to the pharmaceutical industry. “… I think safety would go right off the boards.”


His prediction comes shortly after four former Food and Drug Administration commissioners chimed in with their own dire warnings. In an open letter to Congress, they wrote that importation is “a complex and risky” idea that would harm consumers and compromise the existing safety system.


To be sure, there is reason to be cautious.


Counterfeit medicines have entered the U.S. supply chain before. In one widely publicized episode several years ago, a Canadian company supplied doctors with fake copies of the Avastin breast cancer treatment. And in 2003, a crime ring successfully peddled phony Lipitor pills to wholesalers, some of whom looked the other way.


But this doesn’t mean that importation is impossible.


“We should be able to address the safety issue,” said Dr. Aaron Kesselheim, an assistant professor of medicine at Harvard Medical School who has studied the topic. “To not have the conversation and instead say there’s no way to import medicines safely is a cop-out.”

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Senators Start a New Effort to Allow Importation of Certain Drugs from Canada. Will Trump Play Security Card?

Senators Start a New Effort to Allow Importation of Certain Drugs from Canada. Will Trump Play Security Card? | Pharmaguy's Insights Into Drug Industry News |

Now that Tom Price has been confirmed to head the US Department of Health and Human Services, a trio of lawmakers is after him to allow Americans to import medicines from Canada. And their names are familiar to anyone who has tracked this particular notion, which has regularly been proposed — and just as often ignored or swatted down — as a fix for the vexing problem of prescription drug costs.


In a letter sent to Price on Tuesday, the lawmakers — Senator Chuck Grassley (R-Iowa), Senator Amy Klobuchar (D-Mn.) and Senator John McCain (R-Az.) — urged the newly anointed cabinet member to use his statutory authority to fast-track importation from Canada under certain circumstances. And those circumstances include situations in which competition is lacking or there are sudden and huge price hikes.


This is only the latest attempt by these same lawmakers to find a way for Americans to import medicines from Canada. Over the past couple of years, they have each introduced legislation or written letters to HHS urging importation (read, for example, “Drug Importation Crisis: Terror Politics to the Rescue!”; But given that President Trump has informally voiced support for the idea — and twice attacked drug makers over high prices — they apparently see an opening to renew their call.

Pharma Guy's insight:

Back in 2004, under the Bush II administration, the FDA played the "terrorist trump card" in its battle against the legalization of the reimportation of drugs.Lester Crawford, the acting FDA commissioner at the time,  suggested that "a source of continuing concern" is that terrorists might tamper with prescription drugs imported from Canada. Will history repeat itself?

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PhRMA Lobbying Pays Off Again: Senate Panel Rejects Proposal to Allow Importation of Rx Drugs from Canada

PhRMA Lobbying Pays Off Again: Senate Panel Rejects Proposal to Allow Importation of Rx Drugs from Canada | Pharmaguy's Insights Into Drug Industry News |

A Senate panel on Thursday rejected a Democratic effort to make it easier for Americans to purchase medications from Canada, where prescription drugs are typically sold at significantly cheaper prices than in the United States.


The Senate Health, Education, Labor and Pensions Committee voted 13-10 along mostly party lines to kill the proposal, which was offered by Sen. Bernie Sanders (I-Vt.) as an amendment to bipartisan legislation that would reauthorize Food and Drug Administration programs.


Opponents of easing federal laws on drug importation, including the pharmaceutical lobby, say it could expose Americans to unsafe medicines that haven’t been vetted by U.S. regulators.


“This would put Americans at risk of counterfeit and substandard drugs,” Sen. Orrin Hatch (R-Utah) said at the markup. “There’s no way for Americans to ensure the drug being dispensed in a Canadian pharmacy is the same drug as what the doctor prescribed.”


Sanders said the amendment has provisions to ensure drugs imported from Canada are safe. Opposition to the proposal, he said, is being fueled by lobbying from the drug industry, not out of concern for drug safety.


“This amendment is about whether or not we have the courage to stand up to an industry which has spent more than $3 billion lobbying since 1998 to make certain that we pay the highest prices in the world for prescription drugs,” he said.


The Pharmaceutical Research and Manufacturers of America, the industry’s trade group, said it has concerns about importation proposals in Congress due to safety issues, pointing to counterfeit drugs that reached the United States from China via Mexico and Canada.


“Even Canada has said it does not and would not be able to guarantee that U.S. citizens would receive products that are safe, effective and of high quality,” PhRMA spokesman Andrew Powaleny said. “Guaranteeing patient safety is crucial, and we must have policies that ensure patients safely have access to the medicines they need.”


Further Reading:

Bernie to Trump: “Talk is Cheap.” Stand Up to Big Pharma! Support Importing Drugs from Canada!:

Senators Start a New Effort to Allow Importation of Certain Drugs from Canada. Will Trump Play Security Card?:

Pharma Guy's insight:

This is part of Sanders’ campaign to thwart president Trump’s agenda. However, Bernie is up against a much stronger opponent than Trump – the drug industry lobby headed by PhRMA, which is now firmly in Trump’s camp (read, for example, Big Pharma Struggles to Distance Itself from "Price Gouging" Small Pharma:

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Bernie to Trump: “Talk is Cheap.” Stand Up to Big Pharma! Support Importing Drugs from Canada!

Bernie to Trump: “Talk is Cheap.” Stand Up to Big Pharma! Support Importing Drugs from Canada! | Pharmaguy's Insights Into Drug Industry News |

President Trump and other Republicans have talked about the greed of the pharmaceutical industry. Recently, Trump said (rightly) that Big Pharma is “getting away with murder.” But talk is cheap. The question is: Will Republicans really have the guts to join me and many of my colleagues in standing up to the drug companies to fight for American consumers and end the disgrace of having our country pay by far the highest prescription drug prices in the world? If Trump believes what he has said about the industry, he will rally his party to help save American lives. Here’s why.


The five largest drug manufacturers made more than $50 billion in profits in 2015. Meanwhile, nearly 1 out of 5 Americans could not afford the medicine they were prescribed. The result: Millions of Americans became sicker, and some ended up in emergency rooms at great cost. Others unnecessarily lost their lives.


It is beyond comprehension that while Americans are suffering and dying because they cannot afford the medications they need, the 10 highest-paid chief executives in the pharmaceutical industry collectively made $327 million in 2015. These executives get richer while Americans die. That’s not acceptable.


The root of this problem is that we are the only major country not to negotiate drug prices with the pharmaceutical industry. You can walk into a pharmacy today and the price could be double or even triple what you paid for the same medicine a year ago, and there are no legal barriers in place to stop these arbitrary increases. Pharmaceutical corporations can raise prices as high as the market allows. If people die, it is not their concern. If people get sicker, it is not a problem for them.


Yet, 50 miles from my home in Vermont, the same medications manufactured by the same companies in the same factories are available for a fraction of the price. A 90-day supply of Januvia, which treats diabetes, is $505 in the United States but $204 across the northern border. A 90-day supply of Advair, used in asthma inhalers, costs about $222 in Canada and approximately $464 in the United States. A year’s supply of one of the most important treatments for advanced prostate cancer, Xtandi, is sold for about $30,000 in Canada. Patients here pay about $130,000.


Outrageously, our government, and therefore U.S. taxpayers, paid for research that led to Xtandi’s discovery.


This state of affairs is unacceptable. Until recently, Trump agreed. Yet after one meeting with pharmaceutical lobbyists, the president started reversing course. Instead of negotiating drug prices down, he talked about cutting taxes for drug companies that already make billions on the backs of American consumers.


Again, this cannot continue. That is why I am introducing legislation to end this insanity, allowing Americans to buy the same drugs they receive now, but from Canada, at far lower prices.

Pharma Guy's insight:

Further Reading: “Sanders to Challenge Trump to Support Allowing Medicare to Negotiate Drug Prices”;

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