How to Proactively Protect a Health-Care Company

The war on drugs doesn’t begin with the police—or at least, it doesn’t need to. Pharmaceutical company Purdue Pharma is directly responsible for one of the most significant successes to curb substance abuse.

In 2001, Purdue Pharma, the maker of prescription pain reliever OxyContin, began a nine-year process to reformulate the product and incorporate abuse-deterrent properties. The company changed the physical properties of the medicine to make it extremely difficult to crush in order to snort it. The company also made it unsuitable for injection with a syringe—when mixed with water, OxyContin creates a gummy substance.

This change to one of the most popular pain relievers didn’t happen organically. Robin Abrams joined Purdue Pharma in July 2002 and was part of the team that crafted the strategy to reformulate OxyContin. Purdue Pharma had to procure approvals, craft studies, and disseminate research regarding the reformulation before it could be attempted, let alone completed successfully.

Today, Abrams says the initiative was a rare opportunity for her to be involved in an innovative approach to address a serious and endemic public health problem.

Abrams collaborated with colleagues to help policy makers and regulators understand the goals of companies reformulating opioids with abuse deterrent properties, such as OxyContin.

In the years following the first submission of an application for approval from the US Food and Drug Administration (FDA), Purdue Pharma convened multiple mock FDA advisory committee meetings in which Abrams played the role of an FDA panel member trying to understand the key aspects of the reformulation and asking tough questions. Ultimately, those efforts resulted in approval.

The team worked proactively to improve their chances of receiving regulator approval quickly, and they met with Purdue Pharma scientists, members of the US Congress, health-care experts, government representatives, and independent organizations to guide evolving national drug policy. “This was a much broader strategic role than a lawyer would usually undertake,” Abrams says. “I was part of a multidisciplinary group that sought to identify goals and determine how we should study the impact of the new formulation before it was even approved.”

Abrams believes Purdue Pharma’s size made it possible for her to play such an active role in developing the company’s strategies. “We’re a smaller company, which creates opportunities to engage in much more collaborative and innovative ways,” she explains. “I was not limited to providing legal advice relevant to the registration and approval of Purdue Pharma’s products, but rather integrated into crafting and executing the business priorities on a regular basis.”

Purdue Pharma recognized early that the abuse of prescription opioids isn’t just a matter of concern to regulators; it is a national health emergency that impacts individuals, families, and communities. To address this complex public health issue, Abrams advocated for stakeholder engagement as part of Purdue Pharma’s comprehensive approach to address abuse.

Abrams believes the pharmaceutical industry can play an important role in prevention by developing medicines that are harder to abuse and misuse. “We don’t want to generate a single prescription other than those for the right patient who will benefit from the medicine at the right time,” Abrams says.

The successful reformulation of OxyContin had challenges. Two separate FDA advisory committees had to approve the new version of the drug. Purdue Pharma promised the FDA it would conduct a silent switch of the product, which generated many questions from patients, caregivers, and prescribers who noticed small, unexplained changes in the widely-used medicine.

The FDA approved the reformulated version of OxyContin in 2010 after studies showed that the new formula reduced abuse by an average of 40-50 percent.

Abrams says the company’s efforts with OxyContin were just the beginning and ultimately led to broader efforts to effect change. “Our approach goes beyond a single product to a broader internal research and development and external engagement strategy,” she says. “Creating multistakeholder collaboration and building a practical framework for broad change is a challenge that remains a high priority.”

The company appears to be making progress. In 2013, the FDA decided that the safety improvements of the reformulated OxyContin were so significant that generic manufacturers would not be allowed to produce OxyContin in its original formulation. In 2015, the FDA issued its “Guidance for Industry” documents and addressed opioids with abuse-deterrent properties, heavily relying on Purdue Pharma’s best practices with OxyContin to guide future approvals of such products.

OxyContin was a significant step for Purdue Pharma and the industry, and Abrams looks forward to progress in the manufacture of safer generic medications, which make up the majority of the commercial prescription market. “To achieve widespread impact, the entire class of opioid products must incorporate these new, innovative technologies,” Abrams says. “Only then will the medication better serve pain patients and dissuade nonpatients.

“In the meantime, a hallmark of our success is the growing acceptance of the importance of these innovative technologies and the increasing attention that they are garnering,” she adds. “As more groups work toward achieving these common goals, we hope they will realize greater benefits for public health.”