The “Right to Try” – Compassionate Use of Experimental Medicine, 5th Annual Cathy Shine Lecture

SHINE_headerThe “Right to Try” –  Compassionate Use of Experimental Medicine

5th Annual Cathy Shine Lecture

Thursday, March 19, Noon – 1 p.m.
Boston University Medical Campus Instructional Building
Bakst Auditorium
72 East Concord Street, Boston, MA
Free and open to the public
Reception will follow

Is it fair to use social media or personal connections to get experimental drugs? Is it possible to reconcile so-called “right to try” laws—which allow patients access to novel, unapproved treatments—with evidence-based medicine and a drug-approval process charged with ensuring safe and effective medicines? Professor Caplan examines whether the duty to rescue should play a role in regulatory policies, physician advocacy, and corporate behavior in the US. Continue reading

Open Payments: Early Impact And The Next Wave Of Reform

A new post by Tony Caldwell and Christopher Robertson on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

The Physician Payments Sunshine Act, a provision in the Affordable Care Act, seeks to increase the transparency of the financial relationships between medical device and drug manufacturers, physicians, and teaching hospitals. Launched on September 30, 2014 by the Centers for Medicare & Medicaid Services (CMS), the Open Payments database collects information about these financial relationships and makes that information available to the public.

As of early February, the Open Payments database includes documentation of 4.45 million payments valued at nearly $3.7 billion made from medical device and pharmaceutical manufacturers to 546,000 doctors and 1,360 teaching hospitals between August 2013 and December 2013. This included 1.7 million records (totaling $2.2 billion) without the names of physicians or teaching hospitals who received the payments.

These records were intentionally de-identified by CMS because the records had not been available for review and dispute for 45 days, or because the records were not matched by CMS to a single physician or teaching hospital due to missing or inconsistent information within the submitted records. Future reports will be published annually and will include data collections from a full 12 month period. [...]

Continue reading here.

The Medical Innovation Act: Addressing the Shrinking NIH Budget

Senator Elizabeth Warren (D-MA) recently introduced a new bill, the Medical Innovation Act, which would require pharmaceutical companies who settle with the government after committing certain illegal activities to reinvest additional money into the NIH.  Senator Warren views the bill as a “swear jar” for drug companies, seeking to target those who commit certain types of wrongdoing, including violating the anti-kickback statutes or defrauding Medicare and Medicaid, in order to increase government support for research at a time when the NIH’s budget has been falling.  Scholars and researchers who have lamented the shrinking of the NIH’s budget will find much to love in the bill, and they may even wish it had gone farther.

The Medical Innovation Act would be triggered under the following set of circumstances: drug companies (1) who sell at least one drug whose annual net sales exceed $1 billion, (2) where that drug can be traced at least in part to federally funded research (the Act refers to such products as “covered blockbuster drug[s]”), and (3) who enter into a settlement agreement of at least $1 million with the government after committing certain types of wrongdoing, would pay an additional penalty.  As a threshold matter, the Act will not affect companies unless they appear to have broken the law.  But even where companies have committed various forms of wrongdoing, the Act would not affect smaller drug companies, those who developed their drugs without the aid of the federal government, those who engaged in minor wrongdoing (and therefore only have small settlements), or those who take the government to trial rather than settling.

Affected companies would be required to pay an additional fine on top of the value of their settlement, paying 1% of the company’s profits multiplied by the number of covered blockbuster drugs sold by that company each year for five years.  Because the annual profits attributable to these companies are typically very high, even with the Act’s various carve-outs, Senator Warren estimates that if the Act had existed for the past five years, it would’ve provided an additional $6 billion every year to the NIH, a full 20% increase in its budget.  Going forward, this number might be smaller, if some companies respond to the Act’s incentives by committing less wrongdoing (a positive development in itself) or taking the government to trial (a relatively unlikely outcome, but possible in some cases), but the total amount is still likely to be substantial.

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UCLA, CREA, and FDA

By Emily Largent

Before law school, I worked as a nurse at Ronald Reagan UCLA Medical Center.  The work was interesting, as was the news.  I was there when the Los Angeles Times published an investigation revealing that Japanese gang figures received liver transplants at UCLA and when the Times reported on UCLA employees illegally viewing medical records of celebrities.

This week, UCLA made headlines once again when officials announced that nearly 180 patients may have been exposed to a potentially deadly superbug from contaminated duodenoscopes.  Seven UCLA patients–two of whom died–were infected with carbapenem-resistant Enterobacteriaceae (CRE) after a procedure known as endoscopic retrograde cholangiopancreatography (ERCP).  CRE are a family of germs that are difficult to treat because they have high levels of antibiotic resistance, and CRE can lead to death in up to 50% of patients who become infected.

This problem is not unique to UCLA.  The University of Pittsburgh Medical Center had a duodenoscope-related outbreak in 2012. Last month, Virginia Mason Medical Center in Seattle acknowledged that 32 patients were sickened by contaminated endoscopes from 2012 to 2014.  Eleven of those patients died.  From January 2013 to December 2014, the FDA received 75 Medical Device Reports (MDRs) related to possible microbial transmission from duodenoscopes.

The FDA issued a safety communication yesterday, February 19th, which warned doctors that the complex design of duodenoscopes may impede effective reprocessing.  Reprocessing is a multi-step process to clean and disinfect or sterilize reusable devices.  The FDA noted that multi-drug resistant infections have been associated with reprocessed duodenoscopes “even when manufacturer reprocessing instructions are followed correctly.” (UCLA stated that its scopes had been sterilized in line with the manufacturer’s standards.)  Nevertheless, the FDA urged medical providers to carefully follow manufacturers’ cleaning instructions and talk to patients about the benefits and risks of undergoing procedures involving duodenoscopes.

Some have argued that this did not go far enough.  What other options are available to the FDA?

Continue reading

In Regulating E-Cigarettes, No Easy Fix For The FDA

A new post by Wendy Parmet on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

Read the full post here.

Highlights from the 21st Century Cures Act

At the end of January, the House Energy & Commerce Committee released a discussion draft of the 21st Century Cures Act.  This document marks the beginning of the legislative phase of the 21st Century Cures Initiative, during which the Committee has held numerous roundtables and hearings and issued several white papers.  The first discussion draft of the Act, clocking in at nearly 400 pages (even with several sections “to be supplied”), is incredibly wide-ranging, including proposals that could affect every stage of the innovation process.

The discussion draft should be of interest to everyone in the health policy field.  One series of proposals is targeted at the NIH, including more support for the National Center for Advancing Translational Sciences and for the NIH’s BRAIN initiative.  Another set would act on the FDA, including one provision giving new drugs for unmet medical needs the option of 15 years of exclusivity.  This provision, based on the MODDERN Cures Act, is particularly likely to inspire a great deal of controversy and opposition.  The draft also contains a series of proposals designed to promote the development of new antibiotics, in keeping with President Obama’s recent focus on this issue.  Its attention to the use of social media by drug companies and to the FDA’s regulation of health-related software will be of interest to many, as well.

The proposed draft is much too long to catalog fully in this brief blog post, although those who are interested in a broader summary might enjoy the 13-page summary of the Act put out by the Committee, the Science summary by Kelly Servick and Jocelyn Kaiser, or Alexander Gaffney’s comprehensive Regulatory Explainer.  But I do want to highlight one section of the draft which deserves more attention than it has gotten: section 2021, which would create a national Medical Product Innovation Advisory Commission.

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Managing Off-Label Drug Use

Guest Post by Marc Rodwin

Last year Endo Pharmaceuticals paid just under $182 million to settle a Department of Justice prosecution over its illegal marketing of Lidoderm for uses that the FDA had not approved.[1]  This settlement reflects a widespread practice in which pharmaceutical firms illegally promote drugs for off-label uses. In recent years, pharmaceutical firm settlement agreements for off-label promotion have included Johnson and Johnson ($2.2 billion for off-label promotion of Risperdal, Invega and Natrecor);[2] Pfizer ($2.3 billion for off-label promotion of Bextra);[3] and GlaxoSmith Kline ($3 billion for off-label promotion of Avandia).[4]  However, the problem of off-label drug use is more complex than it appears.

Manufacturers are prohibited from marketing drugs off-label, that is, for purposes that the FDA has not found to be safe and effective. However, physicians may prescribe drugs off-label for a different therapeutic purpose, with a different dose or for a different category of patients than that on which the drug was tested. Physicians—with the manufacturer’s encouragement—prescribe off-label much more frequently than is justifiable and risk harming their patients. In fact, 70 percent of off-label uses lack significant scientific support.

Physicians value the right to prescribe off-label, but it is the pharmaceutical firms’ incentive to increase sales that drives this practice. More sales means increased profits, so manufacturers have financial incentives to promote off-label use. The First Amendment protects certain off-label promotion as commercial free speech. Furthermore, manufacturers sometimes engage in illegal off-label promotion when the expected revenue exceeds potential penalties.

Unmanaged off-label drug use compromises good medical practice and the FDA’s ability to protect consumers from unsafe and ineffective drugs. Yet typical reform proposals, such as stronger sanctions for illegal promotion, don’t eliminate the problem. Public policy should manage off-label drug use by tracking off-label prescribing, removing economic incentives to sell off-label, and evaluating the safety and effectiveness of off-label uses.

Continue reading

The Puzzle Of Antibiotic Innovation

A new post by Kevin Outterson on the Health Affairs Blog, as part of part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Dame Sally Davies, the Chief Medical Officer of England, warns that we are approaching an antibiotic apocalypse. A former chief economist at Goldman Sachs estimates that unless dramatic action is taken now, antimicrobial resistance could kill 50 million people a year and cause $100 trillion in cumulative economic damages.

In the US, dire warnings have issued from the Centers for Disease Control and Prevention (CDC), the President’s Council of Advisors on Science and Technology, and the President himself through an Executive Order on Combating Antibiotic-Resistant Bacteria in September 2014 (summary here). The President’s new budget asks for $1.2 billion to be spent on antibiotic resistance. [...]

Read the full post here.

Tomorrow (1/29): A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015, 12: 00 PM

Wasserstein Hall, Milstein West B                               Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

This event is free and open to the public. Lunch will be served.

Efthimios Parasidis is Associate Professor at The Ohio State University Moritz College of Law and holds a joint appointment with the College of Public Health. He is an inaugural member of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy. He has published in leading law reviews and health policy journals, is co-authoring a casebook, and has a book under contract with Oxford University Press. The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

The lecture will be followed by an audience question and answer session moderated by Jacob Gersen, Professor of Law at Harvard Law School and Director of the Food Law Lab.

Cosponsored by the Food Law Lab and the Harvard Food Law and Policy Clinic at Harvard Law School.

Recommended Reading: New Empirical Analysis of False Claims Act Whistleblower Litigation

By Kate Greenwood
[Cross-posted at Health Reform Watch]

Late last year, the Columbia Law Review published David Freeman Engstrom’s Private Enforcement’s Pathways: Lessons from Qui Tam Litigation, the fourth in a series of articles Professor Engstrom has written on the growth and evolution of qui tam litigation. (My colleague Associate Dean Kathleen Boozang wrote about the first three at Jotwell, here.) Private Enforcement’s Pathways, like the articles that precede it, brings a welcome dose of data and empirical analysis to a controversial area of the law, the debate over which has at times generated more heat than light.

Professor Engstrom’s analysis rests on a database he built containing information on the roughly 6,000 unsealed FCA cases that have concluded in a litigated judgments or settlement since 1986. In response to Freedom of Information Act requests, the Department of Justice provided information on the judicial district in which each case was filed, the date that DOJ decided whether or not to join each case, and the outcome of each case (including the amount, if any, that the government recovered and the whistleblower’s share of that recovery). DOJ also provided the date of filing for the 3,000 cases filed since 1986 that remain under seal, as well as for the 6,000 unsealed cases. From PACER, Professor Engstrom retrieved information on the parties, law firms, and individual lawyers involved in each unsealed case. Continue reading

A “Money Blind” for Research into Maternal-Fetal Medication Risk?

By Kate Greenwood
[Cross-posted at Health Reform Watch]

A week ago, the Food and Drug Administration announced the results of a review of the medical literature it conducted in response to “recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.” The literature, FDA determined, is inconclusive. FDA found that all of the studies had “potential limitations in their designs” and that “sometimes the accumulated studies on a topic contained conflicting results that prevented us from drawing reliable conclusions.” As a result, the FDA chose not to update its current recommendations. The agency emphasized, though, that the use of pain medication should be “carefully considered” by pregnant women and their physicians.

One of the reports that triggered the FDA’s review was no doubt this study, published in JAMA in April 2014, which found an association between prenatal exposure to acetaminophen and a higher risk of developing attention deficit hyperactivity disorder. The study led to headlines like Acetaminophen Use While Pregnant Leads to ADHD, Study Says and Mom’s Tylenol Use, Dad’s Age Are Latest Suspects on ADHD Front. At the New York Times’ Motherlode, KJ Dell’Antonia wrote: “If there is a pregnant woman out there willing to take Tylenol after reading this research — or just the associated headlines — I’d be surprised.” But there are serious risks associated with other pain medications, too. Tylenol has long been considered a relatively safe option. Even white-knuckling it is not risk free. As the FDA pointed out in its announcement, untreated severe and persistent pain increases the change that a pregnant woman will develop anxiety, depression, and high blood pressure.

Continue reading

Upcoming Event (1/29): A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

A “Natural” Experiment: Consumer Confusion and Food Claims, a lecture by Efthimios Parasidis

Thursday, January 29, 2015, 12: 00 PM

Wasserstein Hall, Milstein West B                               Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA [Map]

This event is free and open to the public. Lunch will be served.

Efthimios Parasidis is Associate Professor at The Ohio State University Moritz College of Law and holds a joint appointment with the College of Public Health. He is an inaugural member of College of Medicine’s Center for Bioethics and Medical Humanities. His scholarship focuses on the regulation of medical products and human subjects research, the interplay between health law and intellectual property, and the application of health information technology to public health policy. He has published in leading law reviews and health policy journals, is co-authoring a casebook, and has a book under contract with Oxford University Press. The Greenwall Foundation awarded Professor Parasidis a Faculty Scholar in Bioethics fellowship for 2014-2017.

The lecture will be followed by an audience question and answer session moderated by Jacob Gersen, Professor of Law at Harvard Law School and Director of the Food Law Lab.

Cosponsored by the Food Law Lab and the Harvard Food Law and Policy Clinic at Harvard Law School.

FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part II)

The FDA’s public workshop on their draft guidance framework for the regulation of laboratory-developed tests (LDTs) continued yesterday, featuring sessions on three additional issues: 1) notification and adverse event reporting, 2) public procedures for classification and prioritization, and 3) quality system regulation.

Many issues that had been raised during Thursday’s sessions reappeared in the context of these new subjects.  Commenters considered whether and when laboratories should be able to submit one (rather than many) LDT notifications and/or registrations, the relationship between clinical use and risk classification, and the need to be sensitive to the diversity of LDTs and their providers in formulating the final guidelines.  Other, more legal aspects were also raised again, including concerns about redundancy between FDA regulations and those already promulgated by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments, whether the FDA possesses the legal authority to regulate most LDTs, and whether the FDA is required to proceed by notice-and-comment rulemaking rather than acting through the guidance process.  (Litigation is almost certain to arise on these last two topics, about which I’ll have more to say in future posts.)

But I want to briefly highlight one theme that cropped up on both days more frequently than I had anticipated: the role of insurers and insurance reimbursement.  Panelists considered whether insurers or other payers should have a seat at the table when advisory committees are convened to classify and prioritize LDTs for review.  They discussed the effect of FDA approval on insurance coverage, debating whether the proposed regulations would increase or decrease access to FDA-approved LDTs.  But most importantly (at least in my view), they explicitly considered the way in which increased FDA regulation would combine with decreasing insurance reimbursement to decrease incentives for innovation in diagnostic testing.

Continue reading

FDA Holds Public Workshop on Regulatory Oversight of Laboratory-Developed Tests (Part I)

Over the past several months, I’ve been blogging (here, here, and here) about the FDA’s recent forays into regulating laboratory-developed tests (LDTs).  Since the release of the draft guidance framework in October, serious arguments have been made on opposing sides of the issue, and industry groups have made additional moves in opposition to the proposed regulation.  And now, today (and tomorrow), the FDA is holding a public workshop on their draft guidance framework, focusing on a wide range of issues.

Today’s workshop featured sessions on three main issues: 1) labeling considerations, 2) clinical validity and intended use, and 3) categories for continued enforcement discretion.  Many commenters simply presented the unique concerns of their organization and urged the FDA to consider them in finalizing the guidelines, which was helpful when it did seem as if the draft guidance may have insufficiently considered the needs of a particular set of laboratories, such as public health laboratories that focus on testing for infectious diseases like Ebola and chikungunya (about which I’ve also blogged, here and here).

More helpful, though (at least in my view), were the comments of those who sought to provide concrete recommendations for the FDA on the basis of 1) the policy concerns they saw underlying the guidance and 2) the practical effects of implementation that they foresaw.  I’ll illustrate with an example, which hopefully will display the complexity inherent in even the simplest questions that the FDA must answer here.

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Caffeine and the Law

By Emily Largent

Generally speaking, law school goes more smoothly when the law student is caffeinated.  Consider that Justice Elena Kagan was known at Harvard Law School as the “coffee dean” for instituting free coffee for students (and, as an aside, expects to be known as the “frozen yogurt justice” for bringing frozen yogurt to the SCOTUS cafeteria).

Last year, the deaths of Logan Stiner and James Wade Sweatt drew attention to another place where caffeine intersects with the law: the regulation (or lack thereof) of powdered caffeine by the FDA.  Both men died after ingesting powdered caffeine.  One teaspoon of powdered pure caffeine is roughly equivalent to 25 cups of coffee.  Manufacturers encourage consumers to take between 1/16 and 1/64 teaspoon (see, e.g., here), though measuring such minute amounts with common kitchen tools may be impossible.  On it’s blog, FDA observes that the people most drawn to powdered pure caffeine are “children, teenagers, and young adults.”  It is not clear how common it is for individuals to overdose on caffeine powder, as the cause of death may be listed as “heart attack” in many cases.

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The People of the State of New York v. Actavis: Making a Hard-Switch Procompetitive

Actavis is back in the spotlight regarding its allegedly anticompetitive behavior. Last month, the U.S. District Court for the Southern District of New York issued an injunction against Actavis and its subsidiary, Forest Laboratories LLC based on the New York Attorney General’s “product hopping” suit.

The suit concerns Actavis’ attempt to extend monopoly protection for its drug Namenda. Namenda is one of only a few FDA approved drugs to treat Alzheimer’s disease, and the only approved drug in a class of medications that act on the glutamatergic system by blocking NMDA receptors. Namenda is also Actavis’ largest revenue generating drug; it brought in $1.5 billion in sales last year. Unfortunately for Actavis, Namenda’s patent protection is due to expire in 2015. Once the patent protection for Namenda has expired, Actavis should ordinarily expect to see a dramatic reduction in sales revenue, as much as 90% in the first year, as consumers switch to a lower-cost generic version.

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How Should the FDA Regulate Fecal Transplantation Safely and Effectively?

Last week’s issue of the New Yorker featured a terrific article about fecal microbiota transplantation, or FMT.  Much of the article focused on OpenBiome, a nonprofit stool bank spun off from MIT that screens donors, processes samples, and ships them to hospitals around the country.  For those who are unfamiliar with FMT, it is a startlingly effective treatment for recurrent C. difficile infection.  C. diff infections have become among the most common hospital-acquired infections in the United States, causing more than 300,000 hospitalizations and 14,000 deaths annually.  And unfortunately, many of these infections are resistant to antibiotics, with resistance rates rising rapidly.  But FMT may provide a way forward: a recent randomized trial (antibiotics versus antibiotics plus FMT) was stopped early, when 94% of patients in the FMT group were cured, as compared to roughly 30% of those in the antibiotics groups.

Coincidentally, I’ve been working with OpenBiome over the past few months on an interesting question that the New Yorker article touched on only briefly: how should the FDA regulate FMT to best ensure its safety and efficacy?  At present, the FDA is proposing to regulate FMT as a biologic drug.  However, many (including OpenBiome’s co-founder, Mark Smith) have argued that it ought to be regulated like human tissue, which from a scientific standpoint it resembles more closely than it does a small molecule drug, given the challenge of characterizing stool’s active ingredients and providing consistency across batches.  OpenBiome’s Policy Director, Carolyn Edelstein, and I are currently working on a paper examining the pluses and minuses of the FDA’s current approach.  I want to briefly summarize a few key points of our paper here, but essentially we argue that classifying FMT as a drug is simultaneously underregulatory and overregulatory.  Our primary goal is to ensure that patients have access to safe, effective treatments – and that means the FDA should be more involved in regulating some aspects of FMT, and less involved in others.

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The Right to Try Meets the Reality of Drug Approval

By Joan H. Krause

[Cross-posted at HealthLawProf Blog]

Whether it be a social media campaign to convince a company to provide an experimental anti-viral drug to a young cancer patient suffering from a life-threatening infection or the debate over appropriate treatment for high-profile Ebola cases, access to potentially life-saving but unapproved medications remains a controversial issue. Two recent articles, published on the same day, illustrate the difficulty of trying to balance desperate patients’ willingness to try unproven therapies with the very real concerns faced by manufacturers undergoing the drug approval process. The first was a Kaiser Health News article describing the passage of “Right to Try” laws in five states. The second was a brief note in the Los Angeles Business Journal that shares of CytRx Corporation, a biopharmaceutical R&D company, had fallen 9% after the company announced that the FDA had placed a partial clinical hold on its clinical trials after a patient’s death.

Right to Try laws are designed to give patients who have exhausted all other treatment options the right to access investigational medications, devices, and biological products that have met Phase I safety milestones. Right to Try legislation has been enacted in Colorado, Louisiana, Michigan and Missouri, and voters recently approved it by initiative in Arizona. The laws are based on model legislation drafted by the Goldwater Institute, which issued a detailed report on the issue in February 2014. While prohibiting states from blocking patient access to such medications, however, the model legislation does not require manufacturers to provide the products, nor does it require insurance companies to cover the costs. Continue reading

FDA Updates System for Explaining Risks of Meds in Pregnancy

By Emily Largent

On Wednesday, the FDA published the “Pregnancy and Lactation Labeling Rule” (PLLR), which “requires changes to the content and format for information presented in prescription drug labeling . . . to assist health care providers in assessing benefit versus risk and in subsequent counseling of pregnant women and nursing mothers who need to take medication, thus allowing them to make informed and educated decisions for themselves and their children.”  The FDA also issued draft guidance for industry to assist drug manufacturers in complying with the new labeling and format requirements.

The current system, which was developed in the 1970s, uses letters of the alphabet–A, B, C, D, and X–to denote risk, with X being the most dangerous.  The PLLR removes pregnancy letter categories from all prescription drug and biological product labeling.  The new system breaks the risk into three categories: Pregnancy, Lactation, and Females and Males of Reproductive Potential.  Companies will be required to provide a summary of risks, a discussion of the data supporting that summary, and relevant information to help clinicians make prescribing decisions.  The changes go into effect on June 30, 2015.  Labeling for over-the-counter medications will not change.

The PLLR should help many women, as there are more than 6 million pregnancies in the U.S. each year.  Research suggests that over 90% of women use at least one medicine during pregnancy, and about 70% use at least one prescription medicine.  I think the PLLR is a wonderful step to enhance patient education and decision-making.  It will not, however, address our limited current knowledge of the safety of medication use during pregnancy.  About 98% of medicines approved for use in the United States between 2000 and 2010 had limited data to assess the risk for birth defects, for example.  More research is urgently needed, and it’s unfortunate that the rule stops short of requiring companies to conduct studies if none exist.