Federal Level Topics

To help combat the opioid epidemic, on Aug. 31, the U.S. Department of Health and Human Services (HHS) awarded $53 million to 44 states, four tribes and the District of Columbia, to improve access to treatment for opioid use disorders, reduce opioid related deaths and strengthen drug misuse prevention efforts.

Also in August, U.S. Surgeon General Vivek H. Murthy, MD, MBA, sent a letter to 2.3 million American health professionals expressing his concern about the extent of the opioid epidemic and asking health professionals for a commitment to combating the epidemic.

Opioid prescriptions continue to be discussed at the state level as well. In July, 46 governors signed the National Governors Association Compact to Fight Opioid Addiction. The document states the governors’ commitment to fighting the epidemic by, among other steps, requiring that all opioid prescribers receive education on pain management, opioid prescribing and addiction throughout their training and careers.

In Pennsylvania, the State Board of Dentistry voted to adopt opioid prescribing guideline recommendations on the use of opioids in dental practice. The guidelines were announced by Pennsylvania Gov. Tom Wolf on July 29 and were developed by a task force convened by the Department of Health and the Department of Drug and Alcohol Programs.

States such as Maine, Michigan, New Hampshire and Vermont, among others, continue to discuss opioid prescribing guidelines and prescription monitoring program requirements at their board meetings.

State Lobbying on Opioid Issues

In a joint collaboration, The Associated Press and the Center for Public Integrity investigated state lobbying activities on opioids. Manufacturers of opioids formed a coordinated lobby and spent more than $880 million on campaign contributions and lobbying activities from 2006 to 2015. While not vocal in legislative hearings, the opioid lobby met with state senators and representatives one-on-one. Known as the Pain Care Forum, the lobby worked under the radar with advocacy groups and a public relations firm. The drug makers and allied advocacy groups employed around 1,350 lobbyists to fight limits on prescribing and bills meant to reign in opioid abuse. In 2015, patients in the United States received 227 million opioid prescriptions. 

On Aug. 31, the U.S. Food and Drug Administration (FDA) issued a safety communication about the combined use of opioid medications and benzodiazepines and other drugs that suppress the central nervous system. After a review of all available data, FDA issued its strongest warning — a boxed warning — on opioids and benzodiazepines to alert health professionals that these drugs work in a synergistic manner. Patients taking these drugs together have experienced serious side effects, including suppressed and slowed breathing, and deaths have been reported.

Opioids and benzodiazepines are both commonly prescribed drugs. In 2014, within the U.S., 81 million patients were dispensed an opioid, while 30 million patients were dispensed a benzodiazepine. As always, FDA encourages health professionals and the public to file a MedWatch report if a patient experiences an adverse reaction. MedWatch is a voluntary reporting service for health professionals; it is mandatory for manufacturers of medical products.

On Sept. 21, HHS issued a final rule from the National Institutes of Health (NIH) on the requirements for submitting registration and summary results from a clinical trial. The rule builds on prior efforts and intends to enhance the design of clinical trials and prevent duplication of unsuccessful or unsafe trials, increase the efficiency of drug and device development processes, improve clinical research practice, and improve the evidence base that informs clinical care.

NIH also released a policy on the dissemination of NIH-funded clinical trial information. In clinicaltrials.gov, as of Sept. 22, there are 2,219 trials using the search term “dental,” while there are 4,751 trials using the search term “oral care” in the NIH database.

FDA held an open public meeting Nov. 9–10, 2016 to obtain feedback on manufacturer communications of unapproved uses of approved or cleared medical/dental products. Decisions in three recent court cases have changed the landscape for findings in off-label issues. Truthful off-label promotional speech, FDA’s pursuit of misbranding provisions (for statements that were truthful and not misleading), and speech that is solely truthful and not misleading cannot be the bases for a misbranding charge. FDA intends to draft a guidance document to provide a more consistent response to a variety of off-label product issues.

Silver diamine fluoride is one example of a dental product that is used off-label. While it is FDA-cleared as a Class II medical device to reduce sensitivity, it is often used to delay tooth decay. Medical professionals may use medical/dental products in the manner they deem appropriate for their patients.