BY DR. ROGER D. KLEIN, OPINION CONTRIBUTOR — 05/26/18

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In a victory for patient rights, the House passed the ‘‘Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act.” The bill removes the Food and Drug Administration (FDA) as an obstacle for incurable, dying patients who want to try promising experimental medicines that have passed initial safety testing. The bill has been forwarded to President Trump for signature. The president, who has been a strong supporter of the legislation, will soon sign it into law.

Although 40 states have enacted “right to try” (RTT) laws with bipartisan support since 2014, the bill became controversial at the federal level, engendering opposition among some patient groups, providers, and most Democrats in the House. The Senate passed a version of the law by unanimous consent last August.

The House went on to pass a similar but narrower rendition on March 21. However, the House bill became stalled in the Senate after Minority Leader Chuck Schumer (D-N.Y.) refused to allow it to move forward. This paved the way for the House to enact the Senate’s original, less restrictive bill.

The passage of RTT legislation represents an important win for patients who desire more freedom and greater control over their health-care decisions. It also is an important symbolic success for President Trump, who has made regulatory reform a centerpiece of his agenda.

The president came into office with a keen sense that excessive regulation was contributing to our slow growth rate and other economic woes, a view shared by many. He has made extraordinary progress in rolling back regulatory fiats.

For example, in one of his first official acts President Trump issued Executive Order 13771 entitled, “Reducing Regulation and Controlling Regulatory Costs,” which among other things directs federal agencies to eliminate two existing regulations for each new regulation they promulgate. Because of this order, federal agencies in 2017 took 67 deregulatory actions and implemented only three new regulatory measures, netting the economy 8.1 billion dollars.

The costs of regulatory compliance are steep. A 2016 study by the Competitive Enterprise Institute estimated this burden at 1.885 trillion dollars, more than revenues collected by annual individual and corporate income taxes combined, and equivalent to a tax of 15,000 dollars per household per year.

We all want assurances that everything possible has been done to guard us against harm or loss, and to believe we are safe. However, when we rely on regulation to protect us, the reality is not that simple. Regulation inherently requires tradeoffs between costs and benefits, possible advantages versus potential harms.

Overregulation manifests as reduced innovation, stagnant wages, and lost jobs. In health care it can at times also mean lost lives. Overregulation is why your doctor may spend more time looking at her computer screen than looking at you. It is in part why individual health insurance is no longer affordable for millions of people. It also plays a substantial role in the uniquely high prices of many therapeutic drugs.

Right to try seems like a worthy, common sense cause for pushing back against government overreach. After all, if a patient who is facing certain death, in collaboration with his or her doctor, wants to try an investigational medicine that has passed initial safety testing when opportunities for profit have been removed, why should the government stand in the way?

Yet, the FDA classifies the doctor as a researcher and forces that physician to navigate a cumbersome process just to attempt to help a patient. Although FDA’s complex procedure for obtaining experimental drugs has been improved, as recently as two years ago it required a doctor to spend 100 hours completing a form.

There are numerous examples of patients suffering with cancer or from serious infections, like HIV, who have benefited from early access to unapproved drugs. Regardless of the tremendous importance of clinical trials, t every patient who is administered a therapy as part of such research receives that medicine prior to FDA approval.

However, in these studies patients are treated not for their own benefit, but for the benefit of the researchers, their sponsors and society at large. In the absence of a federal RTT law, the government has in effect been coercing sick Americans into becoming research subjects to obtain treatments that could save or prolong their lives.

In the modern era of drug development, precision therapies can be matched to patients genetic characteristics or combat a cancer’s ability to evade human immune defenses. These revolutionary drugs are more likely to be effective and have less chance of doing harm than traditional treatments. Following FDA approval, such targeted therapies are regularly prescribed for uses outside their approved indications, at times with dramatic results.

Government bureaucrats, however well-intended, are people subject to the same biases, misconceptions, and motivations as the rest of us. This includes inherent tendencies to overvalue their roles relative to those of others, expand their influence and authority, and minimize their limitations and deficiencies.

Right to try addresses this natural proclivity for overreach, promoting patient freedom, enhancing individual choice, and probably improving the lives of some patients who would otherwise be without hope.

Roger D. Klein M.D. J.D. is a member of the Regulatory Transparency Project on health care. He is a former adviser to the FDA and HHS. Klein is a member of the Regulatory Transparency Project on health care. He is a former adviser to the FDA and HHS.