The current opioid crisis has been exacerbated by the widespread introduction of fentanyl into America’s illicit drug market. According to the Centers for Disease Control and Prevention and the Drug Enforcement Administration, counterfeit fentanyl has driven overdose deaths to an all‐time high. More than 64,000 Americans died of a drug overdose in 2016. Drug overdoses are now the leading cause of death for those under the age of 50. As policies are considered to address this important public health crisis, a careful balance needs to be struck to ensure that efforts aimed at minimizing the potential for diversion, misuse and abuse do not restrict access for patients with legitimate medical needs. Likewise, it is equally important that these efforts target the central routes by which diversion, fraud and abuse occur as well as address the growing threat fr
om counterfeit fentanyl and other illegally manufactured drugs.

The impact of drug diversion, fraud, abuse and counterfeit opioids goes beyond the toll it brings to the person abusing prescription or illicit drugs. It costs our health care system, our communities and our workforce dearly, not to mention the emotional toll placed on families and friends. It also puts a disproportionate burden on law enforcement officials and first responders, who face the devastating consequences of this crisis daily. Combatting these drivers of substance use disorder and addiction will take a multipronged approach across a broad range of stakeholders, including law enforcement and state and federal agencies and the private sector. The Pharmaceutical Research and Manufacturers of America supports a range of approaches to strengthen law enforcement’s tools and capacity to investigate and
prosecute illegal activity:

• Assess whether current authorities are sufficient to investigate, prosecute and deter the illegal manufacturer and distribution of certain synthetic substances. Synthetic drugs are produced in the lab and their chemical structure is often identical to or different from naturally occurring drugs. When produced clandestinely, they are not typically controlled pharmaceutical substances intended for legitimate medical use. The DEA and state law enforcement continue to face challenges keeping up with criminal organizations introducing illegally produced synthetic drugs, such as counterfeit fentanyl illegally entering the country from China. We support efforts to assess whether any adjustments are needed to DEA’s emergency scheduling authority to ensure prompt scheduling of emerging synthetic drug threats, as well as exploration of whether additional authorities are needed to curb the manufacture, importation, distribution, and use of 2 these constantly changing synthetic substances.
• Expand law enforcement’s ability and capacity to shut down key sources of diversion, fraud, and abuse, including illegal pill mills, rogue online pharmacies and multi‐national criminal organizations manufacturing and distributing counterfeit fentanyl. According to the National Association of Boards of Pharmacy, a review of online pharmacy websites found that more than 90 percent appeared to be operating in conflict with pharmacy laws and practice standards, highlighting the need to maintain a focus on addressing these illegal sites. A key policy priority should be to identify, shut down and prosecute those operating “pill mills.” These facilities inappropriately provide access to controlled substances and are identified through a set of behaviors driven by financial, not medical, interests and have no regard for therapeutic benefit or necessity (e.g., they generally don’t require prescriptions and operate on a cash only basis). We support policies to clarify the regulations regarding legitimate pain management clinics as this will help to ensure clear distinctions between “pill mills” and legitimate pain management clinics and to expand regulations to include references to relevant state statutes and regulations with which legitimate pain clinics must comply, including, but not limited to, any specific training requirements for persons practicing in pain clinics, clinic inspection requirements and state statutes or regulations related to the data and records that pain clinics are required to maintain.
• Assess the DEA’s role and authorities related to enforcing the Controlled Substances Act, including the roles and responsibilities of the more than 1.5 million DEA registrants. Given the growing crisis, an independent review is warranted to ensure that the DEA has sufficient authorities and resources to reduce the availability of illicit drugs and precursor chemicals.
• Support policies and technology solutions that prevent dangerous levels of drug utilization and detect potential doctor shopping behavior, such as drug utilization review programs and mandated use of state prescription drug monitoring programs (PDMPs) when prescribing controlled substances. Tools such as these also facilitate appropriate decision‐making and ensure patient access to needed medicines is not negatively impacted. The U.S. Centers for Medicare and Medicaid Services (CMS), for example, has credited policy changes directing Part D plans to implement improved drug utilization review and apply drug utilization controls for beneficiaries identified as “opioid overutilizers” with playing a key role in reducing opioid overutilization in the program. In fact, since implementing the policy change in 2013, CMS has regularly released data demonstrating a significant and consistent decline in the share of the program’s opioid utilizers flagged as potentially problematic.
• Expand efforts to facilitate coordination across federal public programs, state medical boards and other entities to ensure that prescribers convicted of fraud and abuse are not able to simply relocate and allowed to continue their practices. Steps to improve coordination include:

Mandate the use of PDMPs by all prescribers, including Medicare and Medicaid prescribers, to detect potential doctor shoppers and inappropriate prescribing and to identify and refer potential fraud to appropriate authorities for further investigation, including with state medical boards.
 Assess the adequacy of existing efforts aimed at ensuring the accuracy and currency of CMS assigned provider and beneficiary identifiers and DEA registrant identification and increasing penalties for illegal use of such identifiers.
 Support efforts to expand sharing of information on potentially problematic prescribing. Some state medical licensing boards have expanded their efforts to obtain and share data with other entities regarding inappropriate prescribing.

Ensuring patients have access to needed medicines is critical, but the importation of unapproved medicines, whether from Canada or elsewhere in the world, is the wrong answer.

The United States is the gold standard when it comes to regulating the safety of our medicine supply. Importing medicines from countries that do not have our same strong standards could taint our medicine supply. Without proper Food and Drug Administration oversight and enforcement of laws designed to protect patient safety—which importation schemes would undermine—there is increased potential for counterfeit or adulterated products to infiltrate the U.S. pharmaceutical supply chain, with life-threatening consequences. 

Importation schemes have been proposed at various times as an approach to reducing drug costs. However, these schemes fail to acknowledge that the resources required to ensure the safety and efficacy of any drugs being imported from or passing through other countries into the United States would outweigh any potential savings.

They also ignore that generics comprise more than 90 percent of the U.S. market today and are widely available lower-cost alternatives for patients. Not to mention, the exponentially higher risk of counterfeit, adulterated and substandard products entering the United States and harming patients would be playing Russian roulette with patients’ lives.

Learn more:
Why Drug Importation is Bad for Patients

Sen. Pat Toomey continues to protect Pennsylvania’s seniors by standing strong for free market principles.

He was one of the few members of the Senate Finance Committee to vote against a disastrous Medicare reform plan. The package contains one particularly damaging provision that, if enacted, would discourage drug companies from developing state-of-the-art medicines.

Sen. Toomey deserves praise for opposing it.

The Finance Committee’s plan would restructure Medicare’s “Part D” prescription drug benefit. More than one million Pennsylvanians -- mostly seniors, but also people with disabilities -- rely on this program for affordable drug coverage. Part D is a rarity among entitlement programs.

Rather than providing coverage directly, the government allows private insurers to design and administer Part D plans Insurers compete against each other to sell their plans, which are federally subsidized, to Medicare beneficiaries. This competition has tamped down spending without sacrificing quality.

In its first decade, Part D cost almost $350 billion less than originally projected. Premiums have remained stable over the years. And more than eight in 10 Part D beneficiaries are happy with their plans.

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Pat Toomey Defends Seniors

For more than a decade, Medicare Part D has successfully provided nearly 42 million seniors affordable access to vital prescription medications. This program is often held up as a model of a successful public-private partnership, consistently arriving under budget while maintaining a high satisfaction rate among enrollees. Despite the program’s many successes, there are always ways to improve.

The Centers for Medicare and Medicaid Services (CMS) recently took their first steps toward enacting new policies that could help seniors save more money at the pharmacy counter. In a recently proposed rule updating the Part D program, CMS included a Request for Information (RFI) on ways to ensure that manufacturer-negotiated discounts and rebates are reflected at the point-of-sale for patients. The core of this idea is simple: accountability and more savings for seniors at the pharmacy.

Learn more:
Medicare Part D Discounts

President Trump and every declared candidate for the presidency want to lower drug costs. And, surprise, it’s the president who has made a bold move toward a workable free market solution.

His new proposal cracks down on the price-gouging practices of middlemen in the drug supply chain — Prescription Benefit Managers (PBMs), the mega-corporations that insurers employ to administer their drug benefits. 

The administration’s new proposal impacts Medicare Part D, the federal prescription drug benefit for seniors and those living with disabilities. Beneficiaries can expect more money in their pockets as a result of the proposed rule. Kudos to the president and Health and Human Services Secretary Alex Azar for putting patients first.

The Trump plan imposes new restrictions on how PBMs share rebates and discounts in the Part D program. Currently, insurers hire PBMs to negotiate with drug manufacturers. Typically, PBMs are able to secure big discounts — usually through rebates — by promising to include specific medicines on preferred insurer formularies.

These rebates aren’t pocket change. By one estimate, the average rebate knocks off nearly 40 percent of a brand name drug’s list price. That’s billions of dollars annually.

Read more:
The Illusion and Cost of Drug Rebates