Monthly Archives: February 2017

Reducing Prescription Drug Prices

President Trump has publicly announced that pharmaceutical companies “are getting away with murder” with their drug price offerings. Prominent examples include, Mylan’s six fold price increase for EpiPens, Daraprim’s overnight increase from $13.50 a tablet to $750,  and Marathon Pharmaceuticals announcement that charging $89,000 a year for a drug that’s widely available abroad for about $1,000 a year.  With that said, there has been bipartisan support in curbing costs of prescription drugs. With the repeal of Obamacare on the Republican agenda and consumers displaying outrage at town hall meetings, lawmakers will have to face the task of reducing drug prices in effort to please their constituents.  This article will discuss different ways Congress and the President can work together to reduce drug prices. Specifically, it will discuss the pros and cons for each solution.

Negotiating Medicare Drug Prices

Lawmakers are discussing the option of negotiating drug prices for Medicare Part D. The Kaiser Family Foundation conducted a study where 82% of the public were in favor of allowing the federal government to negotiate drug prices for Medicare beneficiaries.  Further, Democrats (92%), Republicans (68%) and Independents (85%) all support the negotiation of Medicare drug prices. The only problem with this solution is that under the non-interference clause, Health and Human Services (HHS) is prohibited from negotiating drug prices with drug companies for Medicare Part D.  The Medicare Modernization Act of 2003 (MMA) included the non-interference clause to address concerns about CMS using their leverage in purchasing power to pay less for drugs. In response, the non-interference clause was used a bargaining chip to attract market-oriented republican votes.

Although, even if there was a change to the current law, the Congressional Budget Office (“CBO”) asserts that the authority to negotiate prices alone would have a “negligible effect on federal spending”. The CBO suggests that savings can be achieved in defined circumstances. Specifically, CBO recommends establishing a formulary that includes some drugs and excludes others and to impose other utilization management restrictions. However, stakeholders would take issue with the process of HHS deciding what drugs would be included or excluded.  In 2014, HHS proposed a process that included and excluded drugs from a protected list but failed due to backlash. At the time, House republicans were concerned about CMS “disrupting care” and “unnecessarily interfering” with a successful program. The lack of political feasibility may make this solution hard to implement despite its recent support.

Drug Importation

Drug importation is the process of importing drugs from other industrialized countries because their drug price offerings are typically cheaper than the United States. Senator Bernie Sanders is a huge proponent of drug importation and more specifically from Canada. For example, EpiPens cost more than $600 in the U.S. while it costs $290 in Canada.  In January, Bernie Sanders proposed a bill that would allow pharmaceutical distributors and pharmacists to import cheaper prescription drugs from Canada.  On January 17, the bill lost by a 52-46 vote, but not along party lines. Opponents of drug importation often argue drug importation presents numerous safety concerns. For example, other countries may not have a comprehensive drug approval process like the U.S.  and could thus subject Americans to harm.  Another mechanism to import drugs is allowing Americans to personally buy drugs from Canada.  Senator Klobuchar and Senator McCain introduced, the Safe and Affordable Drugs from Canada Act that would allow Americans to order personal prescriptions from Canada creating another option to import drugs to the United States.

Cost Transparency

Lastly, transparency can be used to reduce drug prices. In Maryland the legislature proposed a bill that aims to prevent price gouging by requiring manufacturers to disclose the cost breakdown of drugs that have  $2,500 or more annual price tag, including costs associated with marketing and promotion.  In turn, this would create public pressure on the pharmaceutical industry to lower costs on life-saving medications. However, there are complications with this method because pharmaceutical supply chains are complex.   The supply chain includes many actors who affect the cost of drugs. These actors include pharmacies, wholesalers, distributors, health insurance plans, and the pharmacy benefit managers.

Decisions

Lawmakers have quite a few options to curb the costs of pharmaceutical drugs. Additionally, PhRMA has a strong lobbying arm and could affect lawmaker’s choices. Nonetheless, with any policy decision, negative externalities and unintended consequences should be reviewed and evaluated. Only time will tell what option lawmakers choose to reduce drugs

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Veteran Urgent Access to Mental Healthcare Act

On February 7, 2017, bipartisan members of the House of Representatives introduced the Veteran Urgent Access to Mental Healthcare Act to Congress. The current veterans’ bill under U.S. Code Title 38 only provides health care access to combat veterans who were discharged with an honorable status. The proposed bill purports to extend access to urgent mental health care services to combat veterans discharged from the military with a status that would have otherwise made them ineligible for them.

However, the bill is not without reservations. It still excludes veterans who did not deploy in combat or received a “dishonorable” or “bad conduct” discharge. However, it does extend access to noncombat veterans who were victims of sexual assault and battery and sexual harassment. In addition, the bill proposes access to health care services and to facilities outside of the Department of Defense (DOD) healthcare network in cases where the DOD mental health care professional advises or where service would not be economically feasible because of geographical inaccessibility. Still, pressing issues with regards to the number of available mental health providers and funding remain.

According to the Department of Veterans Affairs (VA), an average number of 20 veterans per day commit suicide. With the Veterans Urgent Access to Mental Healthcare Act, its sponsors are hoping to decrease the number of veteran suicides each year. If passed, the Act would require an independent report based on a study comparing the rate and methods of suicide among combat and noncombat veterans, and between those who have received mental heath care services from the Veterans Health Administration and those who have not.

Besides the significant number of suicides, the bill aims to address the controversies surrounding discharges that are “other than honorable.” Representative Mike Coffman, the bill’s principal sponsor and a combat veteran himself, questions “the nature of the discharges in the first place, and [is] exploring that” issue. In 2015, the National Public Radio reported from its study that about 22,000 Army veterans diagnosed with post-traumatic stress disorder (PTSD) or traumatic brain injury (TBI) were discharged as less than honorable. As a combat veteran from two branches of the military, Representative Coffman believes that the stigma surrounding personality disorders has led to inappropriate disciplinary measures and consequently delayed access proper health care.

Last year, Representative Coffman proposed a similar bill. However, it did not pass the House. The previous bill purported to expand mental health care access to combat veterans that received dishonorable charges or bad conduct discharges; it did not gain much favor then. Now, with fourteen cosponsors, and the current VA Secretary David Shulkin’s assurance that there will be “greater accountability…improved access, responsiveness and expanded care options,” it is curious to see whether the bill will in fact help serve those who have served.

 

 

 

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The Technology That Can Edit Genes

As biotechnology continues to advance, policies must catch up in order to properly regulate the safety and efficiency of technology. One of the popular and controversial advances in the scientific community is genome editing, which occurs when DNA is inserted, deleted or replaced in the genome of a living organism. While genome editing has mainly been used to modify foods, it has also been used on animals, and lately, on human embryos.

The new technology that is advancing gene editing is called clustered regularly interspaced short palindromic repeats (CRISPR). CRISPR allows scientists to alter DNA much more quickly than before, drastically impacting the health industry, since a parent can choose to decrease the risk of high cholesterol, or minimize the risk of getting cancer. According to Randall Lutter, a professor at University of Virginia, CRISPR is different from previous technologies because it can be used to affect heritable traits and thus create organisms with a variety of desired traits. The changes made in human cells could actually be passed down to future generations and would allow individuals to basically choose the traits they want for their children.

Despite some of the advantages of CRISPR, there are some concerns with how it can be used to engineer human embryos. This caused a dispute in the scientific community when the embryos used did not result in a live birth. Some scientists want to continue experimenting with the benefits and risks of genome editing, but others are fearful of the disruption it could cause in the ecosystem.

The 2017 updated version of the Coordinated Framework for the Regulation of Biotechnology describes the current statutory authority and regulatory programs, such as EPA, USDA, and FDA, as well as the safety and efficiency of biotechnology products. Under National Strategy for Modernizing the Regulatory System of Biotechnology Products, also known as The Strategy, the FDA will continue to update and clarify its policies in regards to gene editing, as well as finding new ways to improve coordination with federal research agencies.

Unlike previous technology, CRISPR doesn’t involve transgenics (which is when genes are inserted from foreign species into an animal or plant). Thus, the U.S. Department of Agriculture allowed it to be sold in the market place. However, this doesn’t mean the new device gets approval from the FDA. FDA’s process for approval of new products is somewhat slow. If the FDA does not approve this life changing technology, scientists will be forced in continuing to use older technologies that are not as efficient.

Even though genome editing can save lives, many are still skeptical on whether it should be used on human embryos. More research must be done in order to minimize the risks.  While CRISPR has made modifying DNA much less costly, it continues to raise regulatory and ethical concerns.

 

 

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