Aegis Compliance & Ethics Center, LLP
PhRMA and the Opiod Crisis
Current State of the Crisis
President Donald Trump recently declared the opioid crisis, the deadliest drug epidemic in the United States’ history, a public health emergency. With upwards of 100 million users and the addictive nature of opioids, the prescription and regulation of the drugs must be scrutinized and under strict control. The Pharmaceutical Research and Manufacturers of America (“PhRMA”) is one of the organizations committed to re-establishing regulations to combat the crisis and this article explains their efforts.
The Present Crisis
According to the National Survey of Drug Use and Health, in 2015, over 97.5 million Americans used or misused prescription medication. Fentanyl, over prescription, online pharmacies, and the increasing difficulty of enforcement agencies’ ability to condemn non-compliant prescribers are a few of the causes behind the crisis. One side of the debate, large pharmaceutical companies argue for the benefits of high prescription usage as an indication of a high volume of patients who can access proper care and medication. However, both the providers and the pharma companies must understand when public safety requires certain safeguards to ensure that the medication’s benefits outweighs its risk.
Who Is PhRMA?
Formed in 1958, PhRMA is the pharmaceutical industry’s lobbying arm and represents the country’s leading biopharmaceutical researchers and biotechnology companies. They work closely with the President’s Commission on Combating Drug Addiction/Opioid Crisis, the National Institutes of Health (“NIH”) and the Food and Drug Administration (“FDA”), in a private-partnership. Currently, PhRMA seeks the development of a non-opioid, non-addictive pain medication for long-term addiction recovery. In addition, PhRMA just announced their support for a 7-day script limit on opioid medicines for acute pain. All too often providers prescribe patients a 30-day supply of opioid pills for minor treatments or short-term pain. Overprescribing runs a high risk of new patient-dependence or the resale of excess pills into the wrong hands.
In response to an investigation by the Washington Post and 60 minutes which uncovered the truth behind the 2016 Ensuring Patient Access and Effective Drug Enforcement Act, PhRMA has announced their support behind the Opioid Immediate Suspension Act of 2017. This bill would repeal the 2016 law which weakened the Drug Enforcement Administration’s (“DEA”s) ability to crackdown on non-compliance within the drug industry. It aims to re-establish the previous threshold for the DEA to act, giving it regulatory power the agency has lacked since 1970. “We need to ensure the [DEA] has sufficient controls and authorities in place to prevent illicit diversion of controlled substances.” said PhRMA CEO Stephen Ubl.
The Ensuring Patient Access and Effective Drug Enforcement Act of 2016
The Washington Post revealed that the drug industry spent $102 million dollars lobbying congress from 2014 to 2016 on what many refer to as a “more industry-friendly law”. The Act then passed unanimously in the House and Senate, disarming the DEA’s ability to freeze skeptical shipments (overprescribed shipments or shipments sold to pharmacies associated with the black market). Joseph T. Rannazzisi, the head of the DEA’s division responsible for regulating drug industry, states, “The drug industry, the manufacturers, wholesalers, distributors, and chain drugstores, have an influence over Congress that has never been seen before… to get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows how much influence they have.”
The Act requires the DEA to prove the pharmaceutical company’s actions portray “a substantial likelihood of an immediate threat” which is a much more involved requirement than the 1970 law that allowed freezing shipments which suggested an “imminent danger” to the community. One of the first lines of defense should be preventing the pills from reaching abusers and the DEA must be able to intervene in drug distribution. To succeed, the DEA will need the full-support of Congress and the power to combat drug companies that are non-compliant and who supply pharmacies with unusually large orders of medications while failing to report skeptical orders – especially to those known to have ties with the black market.
PhRMA’s support for repealing the law and supporting 7-day prescriptions brings additional attention to the need for action. Additional congressmen and women have followed PhRMA’s lead by announcing their support for the repeal. Of course, the crisis cannot be attributed solely to pharma companies and their oversight of over prescription. However, equipping the DEA and additional enforcement agencies with the resources required to hold drug companies accountable and ensuring physicians comply with the law is a step in the right direction.