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The Journal Gazette

Sunday, March 12, 2017 10:00 pm

Making America healthy again

Kristin Jones

AB BioTechnologies, an Indiana research company, just announced plans to invest $10.5 million in a new, 23,000 square-foot-facility in Bloomington.

The facility will give the company room to grow – and allow researchers to develop and test new drugs under one roof.

If some lawmakers in Washington, D.C., have their way, though, this could be one of the last biopharmaceutical companies to expand its operations. Several members of Congress are pushing to legalize importation of prescription drugs from abroad.

If enacted, this plan could cripple Indiana’s biopharmaceutical companies – and seriously damage the state’s economy.

It also would rip off American workers and threaten the safety of U.S. patients.

The biopharmaceutical industry has brought countless benefits to the Indiana economy. It’s one of the biggest industries in the state, and the sale of pharmaceuticals and medical devices has dramatically boosted Indiana’s gross domestic product.

Indiana is home to several major drug companies, including Eli Lilly, its third-biggest employer. These companies create tens of thousands of jobs across Indiana.

Biopharmaceutical jobs are particularly high-skilled and well-paid. Scientists, engineers, technicians and everyone in between can find a job in the sector.

The average employee makes more than $150,000. That’s roughly three times more than average compensation across all Indiana jobs.

But these desirable jobs are at risk if we open our borders to cut-rate drug imports.

Foreign drugs are cheaper. But that’s because many foreign governments impose artificial price controls.

Were such medicines allowed into the United States, the foreign price controls essentially would come with them.

U.S. companies would have to match the import prices.

Unfortunately, price controls have a negative effect on medical research and development.

After the European Union implemented price controls, pharmaceutical research and development spending dramatically slowed.

One study estimated that price controls in the EU have led to 500 fewer new medicines being developed and 170,000 fewer scientists being hired.

That’s because price controls prevent pharmaceutical companies from recouping the enormous costs of research and development.

It takes more than $2.6 billion to bring just one drug to market. So when pharmaceutical companies make products at a loss, they lose the incentive to pursue new research.

But when they’re allowed to sell them at market price, they start project after project.

Over the past decade, the United States developed more than half of the new medicines across the world. Losing that commitment to research and development because of drug importation would be devastating.

Patients taking imported medications may unknowingly risk their health.

Without the quality assurance that federal Food and Drug Administration approval provides, unregulated, imported drugs may lack the appropriate levels of active pharmaceutical ingredients or use harmful artificial fillers – meaning that patients don’t get the needed level of benefit from their medications and may get sicker or worse.

Under both Democratic and Republican administrations, the FDA has warned that it is not able to assure the safety of foreign imports.

The number of counterfeit drugs around the world is astounding. In 2015, the FDA seized illegal medicines and medical devices from more than1,050 websites, many of which falsely advertised themselves as licensed pharmacies.

It’s true that health care costs have spiked. But, President Donald Trump and Congress need to pursue policies that don’t cripple the economy or hurt patients’ interests.

For instance, the president could push for requirements for pricing transparency across the health care spectrum, so consumers better understand co-pays and formulary options. Having timely access to this information for patients and providers leads to better clinical decision-making and insurance enrollment decisions.

Trump could modernize the FDA and speed up the drug approval process. That action would inject more competition into the market, thereby lowering drug prices.

He quickly accomplishes this goal by supporting reauthorization of the Prescription Drug User Fee Act, which is set to expire this year.

PDUFA allows the FDA to collect fees from drug companies to make the drug approval process more efficient. Since its inception in 1992, PDUFA has expedited approval of more than 1,500 medications.

Trump also should insist on strong intellectual property protections. These protections are vital for many high-tech American industries.

Without adequate intellectual property protection, firms cannot recoup the high costs of developing new medicines as copycats move in. Strong intellectual property rights drive job creation and economic growth by creating positive incentives for drug companies to invest in research and development.

Trump has said that he will consider Americans first. Preventing drug importations would do just that – allowing Americans to keep their jobs and their health.