Healthcare Reform

Reviving GRAS(E): Bringing Reform to the Drug Approval Process

by Maya Suresh, UMN Law Student, MJLST Staff

Thumbnail-Maya-Suresh.jpgBringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm’s financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.

The negative effect on consumers is what Emily Puchalski hopes to eliminate with the recommendation detailed in her note published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology. In “Bringing Dormant GRAS(E) to Bloom: Reviving The GRASE Concept for Drugs,” Puchalski suggests that a revival of the Food and Drug Administration’s (FDA) “generally recognized as safe and effective” laws and regulations, commonly reffered to as “GRASE”, could minimize the negative effects on consumers. Many drugs, once discovered, have formulations found in earlier drugs that have already been established as safe for consumer use. The GRASE law is grounded in this understanding, and provides a way for these “already established as safe” drugs to get to the market quicker without having to go through extensive clinical trials.

The problem with GRASE however, is that it is very difficult for a drug to achieve GRASE status. Due to this difficulty, GRASE has fallen out of use as manufacturers have stopped trying to achieve the status. Puchalski suggests that if the FDA were to revive GRASE, it could convince manufacturers to apply for GRASE status, allowing already established safe and effective drugs to come to market more quickly, thus benefiting consumers.

It would appear that Puchalski’s recommendation is being heard. In late February Micropharma Limited was able to obtain GRASE status for their new heart health probiotic. Ryan Jones, CEO of Micropharma Limited, echoed Puchalski when he spoke of the benefits the company has been able to reap with the highly coveted status. GRASE status will allow the company to accelerate development of the drug within both the United States and international markets. Further, it provides strong reputational benefits for the company, as it makes clear to the public that Micropharma is committed to investing a significant amount of time and energy into providing safe and effective drugs to the market.

The ability for Micropharma to obtain GRASE status could serve as evidence of a potentially reformed drug approval process. However, the full benefits realized by consumers and the market will only become clear with time.


New Medicine into Old Bottles, Quality and the US Medical System

by Eric Nielson, UMN Law Student, MJLST Staff

Thumbnail-Eric-Nielson.jpgThis entry discusses some of the challenges identified in Grout et al.’s article Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications from Volume 14.1 of the Minnesota Journal of Law, Science, and Technology. If you don’t have any health problems, have family with health problems, or pay taxes then the problem probably doesn’t impact you. The rest of this paragraph is about me establishing my credentials on the subject, if you don’t care, feel free to skip ahead. I have worked as an R&D engineer developing medical devices for more than 15 years. I have a Masters in Medical Engineering from the University of Washington. I am an inventor on several medical device patents. I have worked for a very large company and for several startups. I have conducted market research, physician training, product design, FDA filing preparation, process development, product development, and implementation, etc. I have worked at nearly every stage of medical device development. Devices I have worked on are in literally millions of people in the United States.

The medical delivery system in the United States is fundamentally unchanged in its approach to quality management since the sixties, with the notable exception of anesthesiology (consider how, malpractice pressure forced reform of anesthesiology in the 80s). The public sector of our economy had to make major revisions when foreign competition in the eighties meant that domestic manufacturing could not compete with other countries. American automotive manufacturers took it in the chops because they could not effectively compete with Japanese and Korean companies. Only in the last decade have the automotive manufactures achieved economic efficiencies similar to their competitors (and finally shed some of their legacy costs). Hospitals and private practices never had this wave of foreign competition and so have never had to reinvent themselves to stay in business. Hospitals are heavily subsidized both directly by the taxpayer and through the federal system. The result has been local monopolies with limited real competition, just like the big three automakers before the Japanese entered the picture.

Japan did not invent quality manufacturing. Japanese industry was known for cheap, poor quality goods well into the sixties. What changed is that Japan got serious about producing quality products as a way to compete internationally and move up the value chain. To do this they relied on the work of several notable Americans: Demming, Juran (University of Minnesota graduate), and Crosby. These three together with Taguchi constitute the key founders of the discipline of Quality Management. There are some key concepts that I want to explore in relation to medical providers.

1) “Quality is free.” It is inherently cheaper to do it right the first time than to have to fix it. It is cheaper to spend more on the process to make it so reliable that you don’t have to continue to monitor the output. Your current business is probably externalizing the costs or hiding them and thus minimizes the real cost of defects in the products you make. Time and money are spent to prevent customers from knowing what the actual quality of health care provided by hospitals.

2) Nobody understands the problem better than all of us together. To find the best solution, you need to understand the system from the point of view of everyone who interacts with it. This requires that line personal have the ability to discuss problems and solutions without fear of negative job impact. This does not exist in modern hospitals. Nurses and staff doing the work are not free to identify problems or concerns with physicians. Decisions are not made with consensus but are top down, command and control by people with very limited information. This prevents identification of effective, realistic solutions and instead encourages ineffective window dressing committees.

3) Quality improvement depends on good information and systematic effort. Bluntly Medical providers have systematically hidden outcomes information in an effort to prevent the consuming public from being aware of how bad a job they’ve done. This includes not gathering the information, not publishing information they have, and playing malpractice claims to keep quiet. Take a typical medical procedure and go find the published complication rate. Then take those numbers and talk with specialists in that field about those numbers. What you’ll find is that the published data invariably understates the prevalence of complications at top flight institutions. This is generally a result of selection bias, where only data sets with exceptional outcomes are submitted for publication (so as not to reflect poorly upon the institution). In the absence of good information, these Potemkin village studies underestimate the scope and cost of the problem and encourage administrators and staff to ignore the problem. Nobody ever says Institution X published a study with only a 3% complication rate for procedure Y, we need to get our numbers to that level. They instead say, I wonder what their real rate is or I wonder how they selected their patients for that study.

4) Management needs to lead or it will not happen. This is a system problem. This is not a problem of people not doing their jobs. It is not about people not trying to do their best. The highly complex medical delivery system does not hold anyone responsible for the error rate. It doesn’t not impact salaries, reputation, or stock price the way it does at private companies. Look at the response from hospitals that are killing people every day compared with Toyota’s response to the “sudden acceleration” fiasco. Is the executive team involved? Are resources focused on the problem? Etc. FDA holds management personally, legally responsible for failures of the quality systems at medical device companies. The same standard hasn’t been applied to medical delivery systems. Maybe it’s time to apply this principle outside of Anesthesiology.


Improving Healthcare Quality: Electronic Prescribing

by Johanna Smith, UMN Law Student, MJLSTStaff

Thumbnail-Johanna-Smith.jpgA new study published online on February 20, 2013 in the Journal of the American Medical Informatics Association found that when hospitals used electronic prescribing, it prevented 17 million drug errors–and if implemented more widely and consistently, it could prevent more than 50 million drug errors. But as of 2008, only about one in three acute care hospitals used electronic prescribing. Although there are various methods suggested to improve healthcare quality, one of the simplest is to make medical errors public. If hospitals, and the general public, were more aware of the safety benefits of electronic prescribing, this could lead to increased use and standardization. Another option to increase the use of electronic prescribing is to connect funding or reimbursement to the use of electronic prescribing.

An article in the January 23, 2013 Journal of the American Medical Association reported that once Medicare and Medicaid stopped reimbursing costs due to certain medical errors, the number of times a foreign item was left in a surgical patient dropped by half. The authors note that this number may not be truly accurate, since the hospitals would have financial incentives to hide the errors. Currently, reporting relies mainly on self-reporting by the hospitals, which is not always accurate. A new article in the Minnesota Journal of Law, Science, and Technology (MJLST) by John R. Grout, John W. Hill, and Arlen W. Langvart entitled “Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications,” discusses how to mistake-proof medicine and looks at healthcare quality on a broader level, including electronic prescribing. The MJLST article highlights that many hospital administrators are concerned more with the finances of the hospital than with patient safety. Connecting these two items increases the probability that patient safety will become a priority for hospitals. Although electronic prescribing is not a complete fix for incorrect prescriptions, it is an important part of improving the process. Compared to the cost of medical errors–including incorrect prescriptions–mistake-proofing is generally less expensive.


States Move to Implement Health Insurance Exchanges

by Brianna Rohne, UMN Law Student, MJLST Articles Editor

Thumbnail-Brianna-Rohne.jpgProponents of the Affordable Care Act breathed a collective sigh of relief in June 2012 when the U.S. Supreme Court upheld most of the law in its decision in National Federation of Independent Business v. Sebelius. As Minnesota Lawyer reports, the health care law will have a major impact in 2013 as state and federal agencies rush to implement the ACA’s key features.

Chief among those features are the Health Insurance Exchanges, which are insurance marketplaces designed to help carry out the ACA’s key feature–the individual mandate–by simplifying the process for purchasing health insurance for consumers and small businesses in every state. As Kathleen Sebelius comments, the Exchanges will provide “one stop shopping for health insurance with better information about plan benefits, quality and cost.” The Exchanges, which will be administered at the state level, must be ready for open enrollment in October 2013 and full operation on January 1, 2014.

Department of Health and Human Services rulemaking has stressed flexibility in the creation and operation of the Exchanges, encouraging each state to take the lead in shaping their Exchange in a way that best accommodates local needs and market conditions. For example, states may choose the type of entity to operate the Exchange, limit the insurance plans eligible to participate, and partner with other states to establish regional Exchanges. HHS also offers support in the way of formal partnership, grant funding, technical assistance, and guidance on key topics.

HHS also allows states to opt out of Exchange planning altogether, leaving it up to the federal government to implement Exchanges in those states. As of early January, the New York Times reported that 23 mostly Republican-run states had indicated that they will not set up their own Exchanges. Another 17 states and the District of Columbia are moving to set up their own Exchanges and seven states have asked to collaborate with the federal government.

Ensuring health coverage and subsequently affordable health care for millions of uninsured and under-insured Americans is an ambitious undertaking, fraught with challenges that states and the federal government are just beginning to work through. In a recently published article from the current issue of the Minnesota Journal of Law, Science and Technology titled Developing a Durable Right to Health Care, Erin C. Fuse Brown discusses the momentous shift in policy accomplished by the ACA’s statutory right to health care. She goes on to warn that the ACA’s right to health care is fragile–especially early in its lifespan–and faces significant political and market challenges. Ultimately, the success or failure of the ACA’s most ambitious goals may become apparent as the federal government and states begin its roll-out over the next few years.