FDA Is Government Health Authority Responsible for Balance Between Safety & Effectiveness When Approving Medicines for Sale in U.S.

Almost 18 million Americans rely on prescription opioids to treat long-term, severe pain as of 2019.[1] An estimated 52 million Americans (20.4%) report suffering from chronic pain and 18.9 million (7.4%) report suffering from high-impact chronic pain.[2]

The FDA’s Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the U.S.[3]

FDA: Minimizing Abuse - Treating Pain

State Laws Required Doctors to Prescribe Painkillers When Needed, & Punished Doctors When They Did Not Adequately Treat Pain

The New York Times

Pain Relief

“In a survey conducted last year, Joranson’s group found that 8.1 percent of state medical board members questioned knew of doctors who had either been investigated or disciplined for undertreating pain.”

October 13, 1998[4]
The New York Times

A Shift in the Treatment of Chronic Pain

“Nineteen states now have laws that protect doctors from prosecution by state and local law-enforcement agencies for overprescribing painkillers so long as the medications are needed to treat pain caused by medical disorders. ”

August 9, 1999[5]
The New York Times

Oregon Board Disciplines Doctor for Not Treating Patients’ Pain

“…in this week’s case, the board found that Dr. Paul Bilder of Roseburg, Ore., had not prescribed enough drugs to alleviate pain in six patients between 1993 and 1998.”

September 4, 1999[6]

Purdue Created OxyContin After Global Medical Community Expressed Grave Concern About Undertreatment of Pain

Prescription opioids are necessary for treating pain when other medications are inadequate. OxyContin was created by Purdue in response to a serious public health concern for treating patients in chronic pain. Since its introduction in 1996, OxyContin has been approved for use in 53 countries.

“Several recent studies, which describe continuing opioid therapy in patients with pain of non-malignant origin, report that continuing use of opioids is not associated with substance abuse or psychological dependence…”

“… A misconception by doctors, nurses, and patients to the effect that physical dependence and psychological dependence are interchangeable terms has led to the under-use of opioid analgesics; lack of professional knowledge about their clinical pharmacological properties has further limited their effective use.


1986[7]

“Despite good intentions and genuine concern for patients’ comfort on the part of physicians, repeated evaluations of the state of pain therapy over the past 20 years suggest that many patients do not receive adequate pain relief.


1995[8]

“In 1982 I wrote an editorial in The New England Journal of Medicine, which began, ‘Few things a doctor does are more important than relieving pain.’ I still believe that. I ended with these words: “Pain is soul-destroying. No patients should have to endure intense pain unnecessarily.”


Dr. Marcia Angell, Former Editor-in-Chief of the new England journal of medicine, 2018[9]

To This Day, Medical Experts Believe Ensuring Proper Access to Opioid Treatment Is Important

“FDA’s efforts to address the opioid crisis must focus on encouraging ‘right size’ prescribing of opioid pain medication as well as reducing the number of people unnecessarily exposed to opioids, while ensuring appropriate access to address the medical needs of patients experiencing pain severe enough to warrant treatment with opioids.”


January 2019[10]

It is imperative to ensure that patients with painful conditions can work with their health care providers to develop integrative pain treatment plans that balance a focus on optimizing function, quality of life (QOL), and productivity while minimizing risks for opioid misuse and harm.”


May 2019[11]

More than 300 health-care experts told the Centers for Disease Control and Prevention Wednesday that the agency’s landmark guidelines for the use of opioids against chronic pain are harming patients who suffer from long-term pain and benefit from the prescription narcotics.


March 2019[12]

Undertreatment of pain is a serious problem in the United States, including pain among patients with chronic conditions and those who are critically ill or near death.”


DEA & 21 HEALTH ORGANIZATIONS, 2001[13]

Pain is a significant national health problem… costing the American public more than $100 billion each year.”


1998[14]

FDA-Approved OxyContin Can Effectively Treat
Chronic Pain Patients Safely When Used Properly

The FDA is the government health authority responsible for the balance between safety and effectiveness when approving medicines for sale in the U.S. Purdue’s marketing material was reviewed by the FDA and consistent with the FDA-approved label.

OxyContin was and still is approved by the FDA as safe and effective for its intended use.[15] Health-care experts are still currently advocating the use of prescription opioids to treat chronic pain.

Purdue’s medicines can only be obtained lawfully through a physician’s prescription. The doctor, in consultation with the patient, determines the appropriateness of opioids for that patient’s specific circumstances, taking into consideration the known risks.

Properly prescribed opioids are essential to the treatment of chronic severe pain and offer relief to millions of people.

The risk of abuse, addiction, and death has always been prominently disclosed in OxyContin’s original and subsequent labels.

Doctors & Patients Continue to Express Need for OxyContin

In April 2020, CDC and HHS requested comments “concerning perspectives on and experiences with pain and pain management” to help update the 2016 guidelines on opioid prescribing.[16]

CDC and HHS requested comment

“I am only able to function daily because of the Oxycontin Extended Release.”[17]

“… I have been on oxycontin ER for 14 years and it has been life changing for the better. When the CDC changed the guidelines in 2016 my Dr was threatened and he had to taper me down to the 90mm suggested by the CDC. For over 3 years my life has deteriorated and my pain is horrible…”[18]

“…taking this opioid drug allowed me to control and manage that pain so I could have some quality of life.”[19]

“…Oxycontin has saved my life!!”[20]

 “I will advocate for the continued legalization and availability of opiate pain medications, including Norco, OxyContin, Dilaudid, Morphine, and Fentanyl Patches, when needed to mitigate chronic pain for pain sufferers like me.”[21]

Abuse of Prescription Opioids Pre-Dates Launch of OxyContin

The abuse of prescription opioids was growing steadily before the launch of OxyContin in 1996. Prescriptions for opioids were rising significantly before OxyContin was introduced. Opioid-related overdose deaths were growing steadily before OxyContin was introduced.

Opioids are recognized by medical authorities and approved by the FDA for millions of Americans who suffer from chronic pain. For the vast majority, only a small percentage of patients prescribed opioids develop dependence, and an even smaller percentage become addicted.

All opioids – whether prescription or street drugs like heroin and illicit fentanyl – have been known to be addictive since the Sumerians in 3400BC referred to poppies as the “plant of joy.”[22] Morphine was invented in the early 1800s and known to be addictive.[23] Potential for addiction or abuse involving prescription opioids must be balanced with medical necessity for an individual patient.