Lawmakers may have the prescription for lower drug prices

“All of us have days [that] are transformative, when something happens that we will never forget,” Sanders said on the Senate floor in 2007.

For Sanders, who was a House when he made the trip, that unforgettable moment was when women fighting breast cancer bought cheaper treatments in Montreal.

“I will never forget the look on their face as those women who are struggling for their lives when they bought breast cancer medicine at 10 percent of the cost they were paying in the state of Vermont,” he said.

Politicians have been trying for decades to make it legal for Americans to buy reimported drugs, which would be made in America, sent to Canada and then sold to Americans. Since Canada’s government runs its healthcare plans, it has the negotiating power to drive down prices.

But, legalizing drug reimportation has remained elusive due to fervent opposition from the pharmaceutical industry and lingering concerns that the drugs people buy from Canada could actually come from other countries instead of from American manufacturers.

The Food and Drug Administration has traditionally been wary of endorsing the practice because of safety concerns, and safety advocates have warned that allowing reimportation from Canada could threaten the integrity of the drug supply chain.

Now Sanders and Democrats are trying again, hoping new legislation will make the practice a reality. A new bill introduced by Sanders and 19 other co-sponsors adds new safety provisions that lawmakers hope will address long-standing concerns.

They also hope anger from the public over drug prices, coupled with a promise from President Trump to lower prices, will be enough to overcome opposition from the pharmaceutical industry. Trump’s campaign plan included a call to allow drug buying from overseas.

“It’s true that pharma has a lot of lobbyists and a lot of power,” Rep. Elijah Cummings, D-Md., a co-sponsor who has worked with Sanders for years to fight high drug prices, told reporters. “We have something even more powerful. We have the support of the American people. They are calling on us to act and we need to heed their calls.”

The lawmakers pointed to prices that were lower in Canada, including the allergy drug EpiPen. The allergy treatment’s maker, Mylan, got into hot water when it raised the price of the EpiPen by $600 for a two-pack.

A September poll from the nonpartisan Kaiser Family Foundation found that 71 percent of the public supports importation of cheaper Canadian drugs.

Congress has shown bipartisan agreement on this issue before, but no Republican has signed on as a co-sponsor of the new legislation.

But bipartisanship occurred on a nonbinding amendment in January to a budget resolution that allowed drug reimportation.

The vote failed by a 52-46 vote, but got the support of 12 Republicans. Meanwhile, 13 Democrats voted against the amendment, including some co-sponsors of the new legislation such as Sen. Cory Booker, D-N.J., and Sen. Bob Casey, D-Pa., due to safety concerns.

Booker said during a news conference last month announcing the bill that he was pleased it addressed those concerns.

“I am very proud of the bill that we have, especially because of the safety mechanisms that we have in place,” he said.

The new bill seeks to address safety concerns by requiring someone selling drugs to get registered with the FDA and require buyers to purchase drugs only from sites inspected by the FDA. Patients who want to buy a drug from a Canadian seller must also have a valid prescription.

But whether those provisions are going to be enough to quell years-long concerns is another question.

The Trump factor

It remains unclear whether the latest importation bill can become law, and Democrats are pushing for Trump to play a role by endorsing the bill.

Other Democrats called Trump, to turn his rhetoric into reality.

“He has made promises to the American people about prescription drug prices, and now it is time for him to put up or shut up,” Booker said.

A new bill introduced by Sanders and 19 other co-sponsors adds new safety provisions that lawmakers hope will address long-standing concerns. (AP Photo)

Trump and Cummings discussed the need to lower prescription drug prices last week.

“President Trump expressed his desire to work with Congressman Cummings in a bipartisan fashion to ensure prescription drug prices are more affordable for all Americans, especially those who need lifesaving prescription medications,” according to a readout of their meeting at the White House. “Reforming the Food and Drug Administration and reducing the regulatory burdens on drug manufacturers so as to enhance competition will help accomplish those goals.”

If Trump begins working toward reimportation, it remains to be seen how many Republicans will hop on board.

Among the people who voted for the budget amendment were Sens. Jeff Flake, R-Ariz., and Dean Heller, R-Nev. Both are up for re-election in 2018 and could face tight races.

Yet more conservative senators, such as Sen. Ted Cruz, R-Texas, have also endorsed importation.

During a CNN debate between Cruz and Sanders, the only issue the two seemed to agree on was legalizing importation.

Sanders joked that he would welcome Cruz as a co-sponsor of the new bill. The latest package doesn’t have any Republicans, but that doesn’t dismay Democrats.

“There is bipartisan support for this kind of legislation,” said Casey. “It is … important we do this as one people and that we come together.”

Unpacking safety

To ensure bipartisan support, Democrats point to the new changes and safety provisions in the latest package.

Technically, an American can already legally buy drugs from Canada, but only for certain conditions. The agency does prohibit a U.S. seller or pharmacy from offering drugs sold in Canada, but a citizen can buy such drugs via a website.

The agency has long said it can’t guarantee the safety and effectiveness of medicines bought from the Internet or from overseas.

That lack of a guarantee has played into the politics surrounding drug importation.

A 2000 law allowed pharmacists and wholesalers to reimport FDA-approved drugs that were exported to foreign countries. But, Congress required the FDA to certify their safety, which it wasn’t willing to do.

Then, in 2003, the Senate voted 62-28 to allow Canadian imports, but the proposal was contingent on the FDA’s saying such imports would pose no safety risks.

The agency did not, and the proposal never went anywhere.

The FDA did not comment on whether its thinking has changed regarding the safety of imported drugs.

The agency does allow people to buy drugs or devices for personal use under certain circumstances, including if the product is for a serious disease that can’t be treated in the U.S.

The quantity of drugs must generally be no more than a three-month supply, the FDA said. There are different requirements if the drug is a controlled substance, which can range from opioid painkillers to Adderall.

Federal law prohibits entities such as online pharmacies, the most common way to buy drugs overseas, from selling foreign drugs to American customers.

The agency has long been concerned that allowing Canada to resell drugs back to the U.S. could give makers of counterfeit drugs a window to peddle products to the U.S.

Of particular concern is the use of rogue online pharmacies that pose as Canadian pharmacies but really offer drugs from other countries such as India or China.

One expert said the safety concerns are a “little bit of a red herring.”

“We don’t have reports of mass public health outbreaks from substandard or counterfeit drugs in Canada or in Europe or Australia,” said Aaron Kesselheim, a professor at Harvard Medical School who has researched drug policy. “There is no concern or legitimate concern about the safety of the drug supply in Canada.”

When asked about the potential for rogue pharmacies, Sanders told reporters, “We will not tolerate rogue outfits. The Canadians themselves have very strong safety standards equivalent to our own.”

But one expert said Canada doesn’t have the same safety measures as the U.S. A 2013 law, called the Drug Safety and Security Act, created new security in the drug supply chain to help identify counterfeit or stolen products.

“The way that system works is every package of drug has to have a unique serial number on it and every entity within the system has to be able to track and verify that serial number,” Allan Coukell, senior director for health programs for the nonpartisan Pew Charitable Trusts, told the Washington Examiner.

If a wholesaler or a pharmacy has a product it is concerned about because it is missing a serial number, it must verify that product.

Coukell said the problem is if a pharmacy gets a large supply of reimported drugs from Canada that isn’t serialized per U.S. regulations.

If bogus drugs show up from another source, then the “verification provisions won’t work. They only work if people have the ability to notice that this doesn’t look right.”

Drug safety has been a common argument from the pharma industry against legalizing importation.

“Law enforcement officials have said repeatedly international criminal organizations will seek to exploit drug importation schemes, following the money and falsifying any so-called requirements in order to gain access to the U.S. market,” said Nicole Longo, spokeswoman for the Pharmaceutical Research and Manufacturers of America, in a statement on the latest bill.

Sanders balked at concerns about rogue online pharmacies or that drug importation could allow substandard drugs to reach the U.S.

“The drugs that come in to this country must be 100 percent safe, and we will do that,” he said in response to a question about online pharmacies.

During a CNN debate between Cruz and Sanders, the only issue the two seemed to agree on was legalizing importation. (AP Photo)

He then pointed to the safety of imported foods, saying that salads likely have “many vegetables [that] come from Mexico and countries around the world.

“If the United States can have a regulatory system where we feel confident that the vegetables and poultry and fish coming from all over the world is safe, does anybody have any doubt that we can make certain that brand-name prescription drugs … coming from a country like Canada will be safe,” he asked.

Sanders said that during the debate over the legislation, the pharma industry will bring up safety as a way to try to protect its profits.

“We are going to see opposition, no question about it,” he said. “We have worked overtime to make sure that this legislation makes 100 percent certain that products coming into this country are 100 percent safe.”

No sale

While the new bill includes a slew of provisions to ease safety concerns, it doesn’t address a concern of another variety, namely that the U.S. can’t force a drug company to sell a product to a Canadian pharmacy.

“It is somewhat unclear why a manufacturer would sell drugs to an entity that they knew was going to export it to the U.S. to undermine their own market in the U.S.” said Coukell.

Federal law does allow prescription drugs made in the U.S. and exported to a foreign country to be reimported, but only by the drug’s original manufacturer.

“Even when original manufacturers reimport drugs, the drugs must be real, properly handled and relabeled for sale in the United States if necessary,” the agency has said.

But the drug company is allowed to set the price however it wants, which would be different than selling to a wholesaler that will sell it at a discount.

Drug importation may work only for generic drugs that are made by multiple manufacturers, but those are already sold at a cheaper price in the U.S., Kesselheim said.

A pharmacy in Canada, for example, may want to supply to the Northeastern U.S. and so orders 1 million units of a brand-name drug from the company.

“The company could say no, I don’t want to send you 1 million units,” Kesselheim said. “I will send you what you need for your local community.”

Sen. Bill Cassidy, R-La., raised a similar concern during an interview with the Washington Examiner.

“There are people that could go to Mexico or Canada and pay less for [a drug] than they would in a U.S. pharmacy,” he said. “But if you try and take that to scale, then you dry up the drug market in both of those countries.”

Cassidy was also concerned about what importation could do to innovation, with companies being unable to get their return on investment due to Canada’s undercutting U.S. prices.

“If venture capital invests in a new drug for sale for Alzhiemer’s, then they won’t get a return,” he said.

Kesselheim said importation would work better for multisource drugs that are off patent. In some cases, importation could be used to offset massive price spikes that have dominated headlines in recent years.

For instance, the small biotech firm Turing Pharmaceuticals — then helmed by former CEO Martin Shkreli — ignited a public firestorm when it raised the price of a decades-old antimalarial drug named Daraprim by 5,000 percent overnight from $13.50 a pill to $750.

Daraprim has been on the market for decades and serves only a small patient population. Generic companies in the U.S. didn’t want to make a cheaper competitor because of the small population and the length of time it takes to get FDA approval.

Cummings understands that there are safety and market concerns with legalizing drug importation. However, he emphasized that something must be done on the issue of drug prices.

“I think that the arguments can be made that this can’t be done,” he told the Washington Examiner.

“On the other side of that, we got people dying.”