Philadelphia’s City Council could have fought opioids by placing limits on pharma reps

By Robert I. Field, Ph.D., J.D., M.P.H.

Does the over-prescribing of opioids lie at the heart of the addiction crisis? Some members of Philadelphia City Council along with many public health experts think so. The Philadelphia City Council recently considered a bill to limit the activities of pharmaceutical sales representatives, also known as detailers, who promote prescription drugs to physicians.

The bill would have required detailers to register with the city for a fee of up to $250, wear identification badges, refrain from giving even small gifts like free lunches to doctors and their staffs, and submit the sales materials they use to the city for review.

Philadelphia is fertile ground for selling pharmaceuticals. It is home to several major academic health systems and physician organizations, and the region contains the headquarters of numerous pharmaceutical and biotechnology companies. It also plays host to a large number of medical conventions that generate business for local restaurants and hotels. Opponents of the bill warned it would have encouraged convention sponsors to look elsewhere, driving away the industry, and the jobs and tax revenue that go with it.

In the end, opponents carried the day, and the bill was defeated by a vote of 9-5.

Would the bill have worked? Recent research suggests that it could have.

A study published in 2017 by researchers at UCLA and Carnegie Mellon examined the effects of limits on drug detailing at 19 academic medical centers around the country. It found that the restrictions resulted in fewer prescriptions for brand-name drugs that detailers promoted. The reduction in prescriptions was modest, but clear.

There is every reason to believe that the proposed limits in Philadelphia would have had a similar effect. And fewer patients receiving prescriptions for opioids could have led to fewer becoming addicted. For a plague as serious as opioid addition, even a small reduction in the number of new victims would prevent a tremendous amount of human suffering, not to mention medical and law enforcement costs that go with it.

With the bill’s defeat, Philadelphia’s risk of losing convention business has faded. At the same time, the opioid epidemic continues unabated. The City is left to wonder which threat is the greatest.

This blog post first appeared in the Health Cents blog on Philly.com.

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About the author: Robert I. Field is a member of the Inquirer’s Health Advisory Panel, and nationally known expert in health care regulation and its role in implementing public policy. He holds a joint appointment as professor of law at the School of Law and professor of health management and policy at the School of Public Health at Drexel University.

Generic Drugs and the PTAB

By Gregory Curfman, MD

When the Hatch-Waxman Act was passed into law in 1984, it established the generic drug industry and thereby forever changed the marketplace for prescription drugs. Today 80% or more of all prescriptions are filled with generic drugs, which has resulted in a savings of $1.67 trillion from 2007 to 2016. To incentivize generic drug entry into the market, the Hatch-Waxman Act provides that the first generic company to submit an Abbreviated New Drug Application (ANDA) will have the exclusive right to market its drug for 180 days. This provision, referred to as “first to file,” provides a strong financial inducement to file an ANDA early.

Generic drug manufacturers may seek FDA approval before expiration of patents protecting the brand-name product if they can establish that one or more of the patents is invalid, which may be done by filing a lawsuit in federal court. To provide a second pathway for challenging patent viability, and thereby effect the withdrawal of patents that fail tests of novelty or non-obviousness, in 2011 Congress passed the Leahy-Smith America Invents Act (AIA), which first established the process of inter partes review (IPR), an administrative procedure whereby the United States Patent and Trademark Office (USPTO) may reconsider the validity of a patent it previously granted. To conduct IPRs, the USPTO created the Patent Trial and Appeal Board (PTAB), an administrative board within the USPTO comprising administrative patent judges who, without involving juries, make determinations about patent viability. To expedite the review process, the PTAB is expected to make a judgment within one year of hearing a case. As of July 2017, more than 7000 petitions for inter partes review were filed, and the PTAB issued final decisions invalidating more than 1300 patents. Consequently, this second pathway of review, which involves administrative and not judicial review, may significantly accelerate entry of a generic drug into the market when it is successfully used to invalidate a patent on a brand-name product. 

On November 27, the Supreme Court will hear oral arguments in Oil States Energy Services v. Greene’s Energy Group, a case in which the constitutionality of the PTAB is being challenged. The petitioner argues first that Article III does not authorize the PTAB, as established by the USPTO, to reconsider the validity of patents that have been previously issued by the agency. The petitioner further argues that PTAB inter partes review violates the Seventh Amendment because patents are tantamount to private property and juries are not involved in the PTAB review process as, the petitioner argues, would be required under the Seventh Amendment.

The respondent argues that reassessment of a previously granted patent by the USPTO is consistent with the principle that patent rights are privileges bestowed by the government and that they may be revoked by administrative review (without the involvement of an Article III body). In short, the respondent claims that issuance of patents is a matter of public rights that reconsideration of previously issued patents may be properly performed by an administrative agency without the requirement of juries.

The outcome of this case will be quite important for the regulation of prescription drugs. Should the Court find that PTAB was unconstitutionally established, this would remove an important pathway by which generic drugs currently move efficiently to the marketplace. The remaining pathway, the federal court system, is a slower route to generic market entry, which could have the important result of raising prescription drug costs for consumers, which are already especially difficult to afford by lower-income citizens.

For the purpose of keeping this post concise, I have intentionally omitted many important details relevant to the arguments in this case, but I hope the general concepts are clear. Though I tend to believe that the respondent will prevail in this case, I would be interested in hearing from others who are more expert in intellectual property law and are following this interesting case.

"Right to Try" May Do More Harm Than Good

By Wendy E. Parmet and Elisabeth J. Ryan

When the Senate approved the “Right to Try Act of 2017” on August 3, Republican sponsor Senator Ron Johnson hailed it as a law that helps “real people facing their mortality with no hope.”  The bill allows patients with “a life-threatening disease or condition” who have “exhausted approved treatment options” to go directly to pharmaceutical companies and request access to drugs or devices not yet approved through the traditional process.  The bill does not, however, require those drug companies to grant any such requests.  It also does not address how much drug companies can charge those patients for access. And the rhetoric hailing it as a savior for patients “with no hope” ignores the fact that the FDA already has an Expanded Access (Compassionate Use) procedure that allows patients to access investigational medical products outside of clinical trials.  In fact, the FDA has approved over 99% of such requests, some in as little as 24 hours in emergency situations.  So the “Right to Try Act of 2017” wouldn’t actually create any new access rights; rather it would end the FDA’s oversight role.  In addition, the “Right to Try Act” would immunize drug companies and prescribing physicians from liability that may arise from a patient’s use of an unapproved drug or device (or from the denial of access to those drugs and devices) except in cases of “reckless or willful misconduct, gross negligence, or an intentional tort.”

Thirty-seven states already have “right to try” laws, which have been pushed heavily by anti-regulatory, libertarian efforts.  These laws have often passed with virtually no opposition because many health professionals and politicians fear “being seen as opposing any one patient’s question to save his or her life.”  But states don’t actually have the authority to regulate drug approval and such laws affect little in practice.  In fact, as Professor Rachel Sachs stated, "It’s telling that although 37 states have adopted these laws, when asked to provide examples of success stories, one of the primary groups pushing for their adoption can only provide the testimonies of six patients who received access to experimental medicines through a single physician in a single state."

Federal legislation has the potential to seriously undermine not only regulatory protections, but also the “integrity of clinical trials, which remain the safest way for patients to try experimental drugs.”  To qualify for the bill’s “right to try,” patients must be “unable to participate in a clinical trial,” but what that means remains unclear. If the language is read broadly to include not only patients who fall outside a trial’s parameters, but also those who cannot access trials due to other reasons (such as distance from a trial site), the bill might reduce patients’ willingness to participate in clinical trials which are vital to protecting population health by gathering evidence as to the safety and efficacy of new drugs.  Perhaps the better solution would be to expand the population of eligible participants for clinical trials.  As Kelly McBride Folkers says in the prior linked article, “Not only are the sickest individuals often denied spots in a clinical trial, but people of color, women, those who live in rural communities, and those without adequate insurance are vastly underrepresented in clinical trial populations.  Their absence greatly diminishes the utility of the data gathered from these trials.”  Finally, the FDA needs more oversight of unapproved medical devices, not less.  “The agency’s guidance protects patients from exploitation, as well as from well-intended but misguided therapeutic attempts that can cause even more harm or pain than patients are already experiencing from their underlying disease or condition.”

Senator Johnson refused to allow a Senate vote on the FDA budget unless the “Right to Try” legislation was attached to it, fast-tracking its approval with minimal debate; the House may subject it to more scrutiny.  The bill, however, remains politically risky to oppose, which could result in harm far more difficult to articulate than “hope for the hopeless.”