Author: Peter J.

Canada Cannot (And Doesn’t Want) To Be America’s Pharmacy

Drug importation is no longer a pipe dream. Now it’s a pipe bomb. The Department of Health and Human Services recently floated a proposal, dubbed the “Safe Importation Action Plan,” to allow Americans to use Canada as their personal pharmacy.

The FDA has stated over and over again that our government cannot vouch for the safety and efficacy of Canadian medicines. Pushing this policy through would needlessly threaten patient health and well-being. And, it’s infeasible— Canada simply doesn’t have enough drugs to share with the United States.

The Safe Importation Action Plan offers two paths forward for drug importation. First, states, wholesalers, or pharmacists could submit plans for demonstration projects for HHS to review outlining how they would import Health-Canada approved drugs. Second, manufacturers could import versions of existing FDA-approved drugs into the United States.

The plan sounds reasonable enough, but neither the Trump administration or any state that’s been pondering drug importation has ever consulted the Canadian government. Had they done so, they’d see that our neighbors to the north have some serious concerns with the proposal.

Canadian officials have already stated that “Canada does not support actions that could adversely affect the supply of prescription drugs in Canada and potentially raise costs of prescription drugs for Canadians.” These concerns are justified.

Canada is just one-tenth the size of the United States with a mere 37 million people. Given the sheer magnitude of the U.S. population— a whopping 329 million people— there is no way Canada could cover drugs for all Americans.

The strain on the Canadian medicine supply would likely lead to shortages and increased costs for Canadian patients. If Canada filled 10 percent of U.S. prescriptions, Canada’s drug supply would run out in less than eight months, according to one study.

Even if Canada had an endless supply of treatments, drug importation is dangerous. Though the Trump administration’s new plan states that the drugs would be verified before importation, the Canadian government has stated that it cannot guarantee a drug’s effectiveness.

Counterfeit drugs are very common in foreign markets. In fact, one out of ten medications is fake, according to a 2017 report by the World Health Organization. Nevertheless, counterfeit medicine sales add up to billions of dollars a year.

There are two types of counterfeit medicines. The first are cheap copies of commonly sold drugs masquerading as the real thing. They contain few if any active ingredients and have no quality control. Patients who purchase these medications may not realize they’re taking ineffective drugs until their health condition fails to improve.

Other counterfeit drugs are composed of potentially deadly substances. Investigators have found counterfeit medicines that contain everything from paint thinner and antifreeze to arsenic and uranium. From April 2016 to March 2017 alone, Health Canada seized close to 5,500 packages of counterfeit drugs.

Access to high-quality medicines is a crucial issue, but drug importation is not the answer. The Trump administration’s drug importation plan would create more problems than it would solve by jeopardizing Canada’s drug supply and exposing Americans to deadly counterfeits.

Peter J. Pitts, a former FDA Associate Commissioner, is president of the Center for Medicine in the Public Interest.

Seniors: Don’t Forget To Sign Up For Medicare Drug Coverage This Fall

Fall has arrived, which means it’s time for flannels, football, and finding the perfect health insurance plan.

That’s right— nestled amidst all the seasonal festivities is Medicare’s open enrollment season, which kicked off October 15. Seniors will have until December 7 to select their Medicare plans for the coming year.

Seniors have a cornucopia of coverage options to choose from. In particular, they should be thankful for the Medicare Part D prescription drug program, which enables tens of millions of seniors to afford their medications.

Traditional Medicare plans cover physician and hospital visits, among other basic health services. But for many seniors— particularly those battling chronic conditions— basic Medicare coverage isn’t enough. That’s why many beneficiaries purchase supplemental drug coverage through Medicare Part D stand-alone plans, or Medicare Advantage plans that include Part D benefits.

Part D is Medicare’s privately administered prescription drug program. Since 2006, it has helped seniors fill billions of prescriptions. Currently, three in four Medicare beneficiaries— or more than 40 million people— are enrolled in a Part D plan.

Part D plans aren’t one-size-fits-all. In some states, seniors have as many as 30 different plans to choose from, each of which features different premiums, co-pays, and covered drugs.

However, all plans must meet certain standards. For instance, every plan must cover at least two drugs in six vital categories: immunosuppressants, antidepressants, antipsychotics, anticonvulsants, antiretrovirals, and antineoplastics. This regulation ensures that people with severe chronic diseases have a choice of medications.

Plans are quite affordable. In 2019, the average Part D monthly premium will cost just over $32, which is even cheaper than the previous year.

These low premiums are no accident. Part D forces private insurers to compete against one another for seniors’ business. Indeed, insurers negotiate directly with drug companies — and the government is prohibited from negotiating or setting prices. The end result is quality coverage at an affordable price.

Part D is a literal lifesaver. Seniors who enroll in Part D coverage experience an 8 percent reduction in hospitalizations, according to a recent study by Johns Hopkins University and University of Illinois researchers. A 2016 analysis from North Carolina State University, meanwhile, revealed that Part D shrank beneficiaries’ likelihood of developing high blood pressure, which can lead to heart attacks and strokes. Part D has curbed senior mortality by 2.2 percent each year since its implementation, according to a study in the Journal of Health Economics.

Given Part D’s ample plan choices, low premiums, and lifesaving results, it’s no wonder that 85 percent of seniors are satisfied with their coverage.

Choosing the right health plan is crucial — seniors shouldn’t wait for the foliage to change before signing up this open enrollment season.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.

A New NAFTA Must Halt Intellectual Property Theft

As American negotiators push to conclude NAFTA renegotiations, they should prepare to demand stronger protection of intellectual property rights. Robust IP protections would prevent Canada, Mexico, and other trading partners from freeloading off American ingenuity— particularly our medicines.

Development of a new drug is an expensive endeavor, requiring top-tier scientists and equipment and years of clinical trials. There are many false starts and dead ends. Altogether, it costs $2.6 billion to bring a single drug to market.

Intellectual property rights, such as patents, give inventors the chance to recoup this enormous investment. IP protections allow companies to sell drugs exclusively for a limited time.

The United States has some of the strongest IP protections in the world. As a result, it is the world leader in drug development. U.S. biopharmaceutical firms invest more than $60 billion annually in research and development, and they received more than half of all drug patents granted worldwide in 2014.

Unfortunately, however, other countries embrace our inventions while regularly undermining America’s IP. Take our NAFTA partner Canada. Our northern neighbor imposes price controls on drugs. Because of these artificial price caps, Canadians spend up to 55 percent less on pharmaceuticals than Americans. That’s unfair—especially when you consider that the average Canadian’s family income is slightly above the average American’s. The Canadian price caps eat into companies’ research and development capabilities and shift more of the costs onto American consumers, who pay more as a result.

Canada also regularly undermines American manufacturers’ patents. Its courts revoke American patents, enabling Canadian companies to create knockoff copies of our patented drugs. The problem is so bad that the U.S. Trade Representative put Canada on its 2017 “watch list.”

This isn’t just a Canada problem or even just a NAFTA problem. Australia, which has a trade agreement with the United States, promised to notify U.S. patent owners if Australian drug companies want to make a generic version of a U.S. medicine that is still under patent. The notice is designed to give American companies a heads up, so they can take proactive legal action to prevent patent infringement. However, Australia hasn’t been giving U.S. companies this advance notice. It only alerts American firms after Australian generic manufacturers begin marketing knockoff copies of the medicine.

In effect, the Australian government is aiding and abetting patent infringement. It’s helping domestic firms rip off American companies.

Or consider India and Brazil. These countries engage in “compulsory licensing” schemes. Compulsory licensing is legal under international law, but only in limited instances. It allows local companies to produce generic versions of patented medicines in desperate times— such as an infectious disease outbreak. However, India, Brazil, and other nations abuse this policy and allow drug-makers to produce just about any generic without any urgent reason at all, and without the patent owners’ permission.

When other countries steal our IP, American manufacturers lose revenues needed to invest in more research and development. They are forced to scale back operations or postpone new research projects— thereby hurting American workers and patients. American trade negotiators ought to make strengthening IP rights their top priority. The status quo hurts American workers and undermines the creation of lifesaving drugs.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.

Why the FDA should think like a surgeon

BALTIMORE — On a visit to her prenatal physician, Margaret Boeme and her husband received unwelcome news— their unborn baby had a spinal tumor. Several doctors recommended the Boemes terminate the pregnancy, but the couple refused to give up.

Finally, they found doctors willing to perform a risky open fetal procedure to remove the tumor. Twelve weeks later, Boeme gave birth to a beautiful baby girl.

When surgeons take these risks, it’s inspiring. But when the FDA does something similar— in particular, rethinking a new drug’s review pathway so that patients without any options can have one— some consider it scandalous.

That’s just wrong. Like a surgeon, the FDA should follow proper procedures, always. But those procedures should allow for advances in regulatory science— such as the patient voice.

In mid-September, the FDA approved Exondys 51, the first drug specifically indicated for Duchenne muscular dystrophy. DMD is a rare disease that strikes boys as young as three, atrophying their muscles and eventually taking their lives. While clinical trials were incomplete, they did demonstrate that the drug carries few side effects and holds the potential to slow the progression of DMD.

For patients, the FDA’s approval represented a “watershed moment.” Until this drug arrived on the scene, DMD sufferers had no viable treatment options whatsoever. Now, they have a chance to live to adulthood. Yet others insist the FDA made a mistake.

Giant insurer Anthem, for instance, claimed the FDA shouldn’t have approved the medicine since it did not have sufficient evidence. As a result, Anthem is refusing to cover it. The decision will deprive hundreds of patients of their only chance to reach adulthood.

Two doctors even went so far as to say that the FDA approval represents, a “worrisome model” for future targeted drug approvals. They urged the FDA not to approve drugs just because they “show positive effects on the body . . . without actually making any measurable difference in patients’ health.”

In the case of medications for common illnesses, these doctors are correct: There is no compelling need for expedited approval but for orphan diseases— serious and life-threatening diseases that afflict small numbers of patients— expedited approval makes every difference.

The FDA should continue its rigorous scrutiny before granting approval to new medications. But when patients with rare diseases plead with the FDA to clear a drug that’s proven not to be harmful and holds the potential to be helpful— well, then it would be cruel if FDA policy prohibited it.

The approval of Exondys 51 does not mean a free pass for bad science. Rather, it shows that the FDA is rightly supplementing its scrupulous review process with a dose of compassion for patients. By balancing the need for speed, accuracy, and improved public health, the agency has taken the next step towards a 21st century, entrepreneurial regulatory system and positioned itself as an innovation accelerator.

Like Margaret Boeme’s surgeons, the FDA should take a chance when the situation demands it, and like her surgeons, the FDA should be applauded for doing so.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.

Eight Ways Trump Can Make Health Care Great Again

BALTIMORE — President-elect Donald Trump has promised to transform American healthcare. Here are eight policies he should consider that could make health care great again:

  1. Eliminate the Independent Payment Advisory Board— Created by the Affordable Care Act, this board was designed to bring Medicare costs down. But its powers are terrifying — with hardly any accountability, IPAB can reduce access to treatments and drastically alter Medicare payments for hospitals, doctors and other providers.
  2. Redesign State Exchange Subsidies— Experts want the number of young adults in the exchanges to grow to 40 percent to stabilize costs. Trump could accomplish this goal by revamping state exchange subsidies in a way that provides younger adults with the incentives they need to sign up.
  3. Offer Insurance Policies Across State Lines— This action would inject more competition into the health insurance market, forcing insurers to cut costs and offer better care options.
  4. Expedite the Approval of New Drugs— Trump could accomplish this goal by implementing the FDA’s Real World Evidence program within his first two years of office. The program uses real-world data as scientific evidence for regulatory decisions, which helps to speed up drug approvals.
  5. Create an “Innovation Czar.”— A position in the U.S. Department of Health and Human Services, this “czar” would ensure that federal health agencies develop new research models and public health initiatives. This official could also help ensure new and existing regulations foster— rather than impede— America’s innovation ecosystem.
  6. Permit the Sharing of Off-Label Information— Currently, the Food and Drug Administration bars pharmaceutical companies from sharing information about how their drugs can be used to treat conditions for which they aren’t explicitly approved. That ban needs to end. Doctors already prescribe drugs off-label all the time.
  7. Prevent Fraud and Abuse— Our healthcare system is characterized by inefficiencies, fraud, and abuse. Trump can identify available savings in the system— and make sure those savings are passed on to patients.
  8. Empower Americans to Get Healthy— Trump should initiate a creative campaign that inspires Americans to eat better and exercise more. Right now, more than two-thirds of adults are considered overweight or obese. Obesity-related diseases drain our nation of $190 billion every year. But by encouraging Americans to take responsibility for their health, Trump could help to decrease the rate of obesity and save our nation healthcare dollars.

Trump’s first 100 days in office will set the tone for making America healthy again. By following these eight prescriptions, Trump can help make sure patients are front and center— and kick Uncle Sam out of the doctor’s office.

Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest.