Life Science Compliance Update

August 15, 2017

President Trump Declares Opioid Crisis a National Emergency


Working off of the recent recommendations in the interim report issued by the President’s Commission on Combating Drug Addiction and the Opioid Crisis, President Donald Trump has issued a directive to his administration to use all “appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic.”

Some of the immediate actions the Trump administration could take to address the opioid crisis include: (1) approve state waivers to remove the Medicaid Institutions for Mental Diseases (IMD) exclusion, which prohibits the use of federal Medicaid funds for care provided to most patients in mental health and substance use disorder residential treatment facilities larger than 16 beds; (2) negotiate lower prices for naloxone (the drug that reverses opioid overdoses) as suggested by the Commission; and (3) distributing some of the $45 million in the Public Health Emergency Fund. Earlier this week, President Trump suggested the administration would combat the epidemic by focusing on law enforcement and security on the southern border to stop illegal drugs from entering the country.

The emergency declaration may allow the government to deploy the U.S. Public Health Service, a uniformed service of physicians and other staffers that can target places with little medical care or drug treatment, said Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. He said the DEA might be able to use the emergency to require prescriber education for doctors and others who dispense opioids.

This comes after several states (Arizona, Florida, Maryland and Virginia) have already declared emergencies. And in recent months, the Centers for Disease Control and Prevention, the Food and Drug Administration, Congress, physician groups and the insurance industry have taken institutional steps to address the crisis. At the street level, police, firefighters and paramedics now routinely carry naloxone.

Health and Human Services Secretary Tom Price, M.D. issued the following statement on President Donald Trump’s instruction to his Administration to use all appropriate authority to respond to the nation’s opioid emergency:

President Trump is taking strong, decisive action in directing the Administration to use all appropriate emergency and other authorities to respond to the crisis caused by the opioid epidemic. Today’s announcement demonstrates our sense of urgency to fight the scourge of addiction that is affecting all corners of this country.

Traveling the country, we have seen firsthand the devastation this crisis is inflicting on individuals, families, and communities. President Trump’s announcement further punctuates his clear commitment to combating this epidemic and I thank him for his leadership.

Attorney General Jeff Sessions also released a statement,

I applaud President Trump for his leadership in taking this drastic and necessary measure to confront an opioid crisis that is devastating communities around the country and ripping families apart. The death toll of this horrific epidemic reached 60,000 people in 2016, but as horrible as it is to think of that number, it is worse when we look past the staggering statistic and see our children, our moms and dads, sisters and brothers, friends and co-workers. This nation has never seen overdose deaths anywhere close to these numbers, and for each death, many more suffer debilitating addictions.

Just last week the Department of Justice announced its new Opioid Fraud and Abuse Detection Unit and we continue to follow the President’s lead and use every tool we have to combat this deadly crisis.

August 07, 2017

McCaskill Opioid Investigation Expanding


United States Senator Claire McCaskill recently announced that she is expanding her wide-ranging investigation into the causes of the current opioid epidemic by requesting information and documents from four additional pharmaceutical manufacturers and three opioid distributors.

Her requests focus on the distribution of opioids and the efforts leading companies have made to monitor, report, and investigate the diversion of drugs for illicit use. Drug diversion occurs when pharmaceutical products meant for legal use by individuals are transferred to others for illicit use, including through the black market.    

McCaskill’s newest requests for documents and information from opioid manufacturers were sent to Mallinckrodt, Endo, Teva, and Allergan, while a prior request to McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., focused on their distribution of opioid products.

McCaskill has previously requested information related to sales and marketing materials, internal addiction studies, details on compliance with government settlements and donations to third party advocacy groups from major opioid manufacturers.

Initial Requests

McCaskill’s request to distributors McKesson Corporation, AmerisourceBergen Corporation, and Cardinal Health, Inc., included requests for documents and information such as:

  • Internal estimates received from outside vendors or consultants concerning the risk of diversion associated with opioid products. 
  • Any audits of incentive or compensation policies conducted internally or commissioned from outside consultants.
  • A list of any facilities for which the Drug Enforcement Administration (DEA) has suspended or revoked registrations since January 2012, including the date the DEA imposed the suspension or revocation, the reason for the suspension or revocation, and the length of the suspension.
  • Suspicious order notifications provided to DEA regarding opioid orders originating from Missouri.
  • Details of opioid shipments to any Missouri pharmacy, distributor, or other customer.
  • Any compensation provided, whether commission, incentive, or as a factor in a bonus, that is in any way derived or partially derived from revenue or profitability targets or expectations for sales of opioid products.

New Requests

In letters to Mallinckrodt, Endo, Teva, and Allergan, McCaskill requested:

  • Any suspicious order monitoring program implemented, including efforts to monitor, investigate, or report suspicious transactions between distributors and pharmacies and efforts to analyze information related to “chargeback” requests.
  • Any questionnaires sent to distributors regarding their anti-diversion and compliance efforts, and any responses to these questionnaires received.
  • Any other formal correspondence sent to or received from distributors concerning their obligations to monitor, investigate, and report suspicious orders.
  • Suspicious order notifications provided to DEA regarding opioid orders originating from Missouri.
  • Details of efforts to audit or investigate Missouri-based pharmacies, distributors, or other customers.

“This epidemic has reportedly arisen, in part, from the failure of opioid distributors to monitor the flow of hundreds of millions of painkillers to pharmacies across the United States and then on to the black market,” McCaskill wrote. “Under the Controlled Substances Act, drug distributors have an obligation to report suspicious orders of controlled substances, which include ‘orders of unusual size, orders deviating from a normal pattern, and orders of unusual frequency.’”

August 03, 2017

US Senate Passes FDA User Fees, Right to Try and Opioid Legislation

Senate Floor
After many months of debate, both chambers of Congress passed the FDA User Fee Package. This comes after the Senate passed its bill (S. 934) which cleared the Senate HELP Committee in May on a bipartisan basis. The House passed its bill on July 13 (H.R. 2430). The FDA Reauthorization Act (FDARA) renews and enhances the FDA drug, medical-device, biosimilar, and generic-drug user-fee provisions. The bill was uniquely tied to “Right to Try” legislation, and the Senate also passed bipartisan legislation on the opioid epidemic.

Senate FDARA Bill

The politics of the bill were intricately locked in with another member of the Senate’s own legislation. Majority Leader Mitch McConnell (R-KY) committed to taking up an amended version of Sen. Johnson’s right-to-try legislation to the floor in a separate vote, which cleared the way for Senate consideration of the user fee package.

FDA Commissioner Scott Gottlieb informed agency employees via email on July 24th that he would not be sending out any layoff notices to user fee-funded staff “unless and until September 30 had passed without reauthorization.” The publicizing of this policy decision by the Commissioner may have been intended to signal to the Senate that the sky is not falling (yet), but that they need to get to work.

"This program is critical to speeding up the drug approval process, and that's important for everyone frustrated by the time and cost of bringing life-saving drugs to market," McConnell said in floor remarks on FDARA. "Without it, the important work of ensuring that drugs and devices are safe and effective would come to a screeching halt."

User Fees

Specifically, the FDA Reauthorization Act of 2017 addresses several aspects of the FDA’s user-fee provisions:

Prescription Drug User Fee Amendments of 2017

The bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities.

Medical Device User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health. The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards. The bill also revises the types of medical devices that the FDA may accredit third parties to review.

Generic Drug User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications.

Biosimilar User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. The bill sets the annual amount of revenue that must be generated by fees. The bill also extends through FY2022 programs and policies including Critical Path Public-Private Partnerships and support for development of medical products for rare conditions.

Industry Supported

The House and Senate language is very similar, and the House bill was widely supported by industry when it passed in July: “This legislation ensures that the FDA continues to have the resources necessary to carry out its critical human drug review programs, while advancing important patient-centered policies that will help streamline the clinical trial process—the most time-consuming, complex, and expensive step in the drug development process. It also takes important steps to advance patient involvement in drug development and bring patient perspectives more clearly to bear on regulatory decisions. The reauthorization of the biosimilars user fee program, including steps to improve communication throughout application review, will move the needle on getting more affordable biosimilar products to patients in a timely way, once the IP protection expires for new biologics,” BIO President and CEO James C. Greenwood said in a statement.

PhRMA president and CEO Stephen J. Ubl issued the following statement: “Timely reauthorization of the Prescription Drug, Biosimilar and Generic Drug User Fee Acts is crucial to patients in need of life-saving treatments and enhancing the competitive market in biopharmaceutical innovation. The House took an important step in reauthorizing the user fee programs and we look forward to swift action in the Senate on behalf of America’s patients.”

Right To Try

Sen. Ron Johnson's Trickett Wendler, Frank Mongiello and Jordan McLinn Right to Try Act of 2017 (S. 204 (115)) authorizes the use of unapproved medicines by patients diagnosed with a life-threatening illness as long as the drugs in question have already been tested in the first phase of human clinical trials and are continuing on in further FDA-overseen research. Patients must have exhausted other treatment options and be unable to participate in ongoing clinical trials. Reps. Andy Biggs and Brian Fitzpatrick have a similar bill pending in the House.

Johnson's measure aroused concern from the drug industry, public health advocates and some at the FDA. But Johnson threatened to hold up the reauthorization of the FDA user fee programs if he did not get a vote on the bill. A compromise reached by Senate leadership and leaders of the Senate HELP Committee gave Johnson a vote on a revised version of his bill, separate from the FDA user fee bill. The compromise included requiring the FDA to receive reports of safety events that occur in right-to- try situations and forbids patients from being charged more than the cost of production for the medicines.


Additionally, lawmakers passed a bipartisan opioids bill (S. 581), from Sen. Joe Manchin (D-WV), requiring HHS to develop standards for hospitals and physicians to denote a patient's history of opioid addiction in medical records. The legislation directs the FDA to develop standards that: (1) consider the potential for addiction relapse or overdose death if a patient recovering from addiction is prescribed opioids; (2) require that a history of opioid addiction be displayed in a manner " similar to other potentially lethal medical concerns" such as drug allergies; and (3) require medical professionals have access to the opioid information to ensure they can prescribe medically appropriate medication.


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