The Advocacy Project proved a much more challenging paper for me than the Historical Conversations Project. In the HCP, we were told to include very specific content, such as a history of the problem, who to blame for the problem, points of view on the issue and implications today. However, the AP was much more vague. I struggled to find my footing on organization of this paper and transitions. My conference with Emily helped clear up questions about strategically placing various parts of my analysis of the solution and its benefits in the final draft among other content which this draft lacks.

[Advocacy Project Creative Title]

Millions of American families face the looming cloud of rising pharmaceutical drug prices that overshadow the benefits of treatment each year. The price of prescription drugs for terminal illnesses contributes largely to medical expenses that often leads to bankruptcy. In 49 out of 50 states, the leading cause of bankruptcy in 2014 was found to be medical debt (Stech). (Massachusetts was the only state in which, medical debt came in second to loss of income.) Pharmaceutical companies go unchecked as they set astronomical, arbitrary prices on medicines for diseases. Due to the Food and Drug Administration’s (FDA) lack of regulation over pharmaceutical drug prices, the corporations who market and sell the biomedical drugs make enormous profits through price spiking while their consumers are left scrambling to pay for them.

America’s regulation of health policy began in 1984 with the Hatch-Waxman Act, more formally known as the Drug Price Competition and Patent Term Restoration Act. Its purpose encompasses the establishment of cheaper manufactured generic drugs by the pharmaceutical industry. The Act marks the first regulation on drug pricing. Clinical trials, studies, and research that are normally performed prior to FDA approval for new medications are no longer requirements for small-molecule drug equivalents with active properties similar to already licensed medications. The act decreases prices up to 80% (Grabowski 2157). This victory in price reduction is short-lived due to the patent period extension in response to the lack of innovation incentive for brand-name companies in the Hatch-Waxman Act.

The United States increased its patent term to 20 years from the filing date, or 17 years from the issue date in 1995. The revision stands as a response to the Hatch-Waxman Act and the World Trade Organization’s (WHO) standards on intellectual property. The patent period extension provides innovation incentive for pharmaceutical companies by eliminating competing drugs equivalents in the market for lower rates. This permits them to set prices as they wish. According to a study conducted by Ronald J. Vogel, PhD, patent protection grants pharmaceutical companies “a period of above-normal profits for a technically [commercial] …product (1204). Patents also act as a safeguard for biomedical companies, “because pharmaceuticals that are not derived from biotechnology can be imitated easily and inexpensively” (Vogel 1204). Instead the extension causes exclusivity resulting in higher prices for longer.

The Center for Medicare & Medicaid Services (CMS) sets the standards for health insurance coverage and has insured Americans for over 50 years. Today, over 100 million Americans are insured through CMS making it the largest health care insurance corporation in the country. Although the 2006 amendment aims to bridge the gap between consumers and out-of-pocket prescription payments, as of 2003 the “Medicare Prescription Drug, Improvement, and Modernization Act forbids Medicare [and the FDA] from negotiating drug prices” (Tefferi 997). The 2003 Act was not overturned when Medicare Part D was added as a part of the 2006 amendment. The overlap speaks to the contradiction of U.S. law on health care regulations. If neither the largest medical service provider in the country nor the standard regulatory body cannot negotiate drug prices, it grants pharmaceutical companies the leeway to sell drugs at the highest, consumable market value.

The United States House of Representatives Bill 3513 in conjunction with the Mayo Clinic Proceedings will create a comprehensive protection against pharmaceutical companies’ astronomical prices and greed. They cover the basis of international drug equivalents and their importation, negotiations of prices, and FDA review processes in terms of changing the way this country approaches drug treatment programs and paying for them. These policy recommendations encompass preventing delay of generic drugs, patent system reform, increasing competition for medications, as well as enforcing price negotiations with Big Pharma. H.R. Bill 3513 works in conjunction with the Mayo Clinic’s petition to rid the pharmaceutical market of its exclusivity from public acquisition. Such a significant commodity must be available without an “if-clause” attached the life-saving contract.

The recent legislation with H.R. Bill 3513 began with the massive media coverage given to Big Pharma exploiting their ill consumers such as the cases with Turing Pharmaceuticals and Pfizer. Turing Pharmaceuticals, in September 2015, was caught in a controversy that they had increased the cost of Antiretroviral pills (AIDS drug) by more than 5000 percent overnight. After much public scrutiny and national media coverage, the CEO stated that they would “mull over the decision to reduce prices,” but no doubt, intentionally failed to mention how (Harven). In December of last year, Pfizer, one of the largest multinational, pharmaceutical corporations, set the price for a new breast cancer drug at $9850 per month.

The United States House of Representatives’ Bill 3513, the Prescription Drug Affordability Act of 2015, suggests CMS and FDA intervention in the regulating of prescription drug affordability. It states that all drugs covered under Medicare Part D, which includes all inpatient treatments and some outpatient treatments, through drug price negotiations with drug manufacturers, closure of the gap in covered versus not-covered medication, prescription drug rebates, and importation of drugs that are cheaper abroad. It was introduced on September 16,2015 in the House of Representatives by Representative Elijah Cummings of Maryland and on September 10, 2015 in the Senate by Senator Bernie Sanders of Vermont. The bill has not been voted on yet in either the House of Representatives or the Senate.

The root cause of the problem is the lack of regulation by either CMS or the FDA on pharmaceutical drug prices. There are currently no possible way of negotiating with companies, before their market price is set at whatever arbitrary number they choose. This policy not only gives the CMS negotiating power over biomedical firms “on behalf of beneficiaries for drugs covered under Medicare Part D” (H.R.). All other insurance companies will then follow the example of CMS in setting their coverage plans, and adjusting their rates. This means the out-of-pocket expenses for patients will decrease overall. Meanwhile, according to doctors at Mayoclinic, “creating a post-FDA approval review” will allow the FDA to compare any newer versions of drugs to their old ones. This way, if a drug only increases life-span by a matter of a few weeks, but keeps the user suffering while having a much more expensive rate for those few weeks, the medication does not have to be approved. This policy changes the approval process so that it becomes mandatory for drug companies to sit down with the number one insurance provider in the country, CMS as well as the regulatory body for all consumable substances, the FDA. The time for negotiations is a period of 180 days, and within that time, a price should be set and the medication should be well on its way to the shelves. Both the H.R. Bill 3513 and the MayoClinic petition propose to amend the Federal Food, Drug, and Cosmetic Act to allow the importation by individuals of prescription drugs from Canada and other countries. This will result in increased competition rather than the direct source of American drugs. The goal exists to diminish the exclusivity of the drug manufacturing market, as a direct response to free-market regulation of a dire commodity in the United States.

As part of this policy recommendation is stemmed from Congress’s introduced bill, it is a viable option. Both the doctors at Mayo Clinic and members of Congress are slowly adopting parts of other countries’ healthcare system that have been working for years. Other countries have set caps on medication costs, and have had a negotiating body for years, appealing to Big Pharma on behalf of their citizens. Recently, Representative Elijah Cummings of MD, who also introducted the Prescriptoin Drug Affordability Act of 2015 in conjunction Senator Bernie Sanders in the Senate, opens a hearing on “‘Prescription Drug Market: Oversight,’” with drug companies, the FDA, and stakeholders (Committee on Oversight and Government Reform, H.R.). He states that Secretary of State Hillary Clinton wrote letters to the FDA and FTC on “stronger regulatory action…on [drug] companies” (Committee on Oversight and Government Reform, H.R.). He states that Democrats, Republicans, and Independents alike on the necessity to take action on this issue. Even presidential candidate Donald Trump supports. Nonpartisan groups such as the Kaiser Family Foundation fully support the reduction of medical costs and these policies. According to a poll on bills H.R. 3513 and its equivalent S. 2023 support from individual constituents is constantly rising. Currently this bill garnered over 15 congressmen and 2 senators as cosponsors. All this media attention and support only benefits the establishment of standardized prescription drug prices across the nation through these policy recommendations.

This policy is a viable option supported by Democrats across the board. And while there is some opposition with respect to the Republican Party, many centrist Republicans are likely to support the idea of taking action because of outrageous action of pharmaceutical companies. There are multiple sponsors currently in both the Senate and the House, with the bill still undergoing revisions within its respective Committee of origin. However, many tea party candidates are pushing for the repeal of health care regulation period. They believe that no regulation is better than some regulation. While GOP presidential candidates, agree that action must be taken with respect to price gouging, they don’t believe that “Medicare should be the one to negotiate drug prices or that the government should limit drug maker’s profits” (Demko). The very nature of the bill goes against traditional GOP beliefs against government involvement in the free market. The issue is being talked around in the Republican Party. They believe in punishing those who price gouge to bring justice to their constituents, however they do no understand the need to encroach on a for-profit company’s profit margins regardless of the repercussions. Many GOP supporters and endorsers are actually drug corporations who help them raise money and win elections. So the alternative to outright going after preventing the problem and angering Big Pharma, is to attack Obamacare, as GOP party has done, and blame it for the problems in the healthcare industry including pharmaceutical prices.

Pharmaceutical companies verify that even failed attempts cost money that must be included in cost analysis. They declare this as the reason for high research costs, and high overall prices. Recently PhRMA president and CEO, John Castellani, in a statement against presidential candidate Secretary Clinton, stated “her proposal [to lower costs] would turn back the clock on medical innovation and halt progress against diseases that patients fear most” (qtd. in Ferris). Stopping or limiting the cash influx into drug development investments may lead to a shortage of the required drug, a slower process of innovation, and by result more difficult access to the prescription of those drugs. And this is what pharmaceutical companies are threatening with their production of medications. The drug maker corporations are now collecting allies with the insurance company moguls and the two opposing industries are coming together on the idea that regulation of prices will decrease both their profits. Because pharmaceutical drug prices in will be regulated as effect of this policy, the device industry may be affected next. This domino effect does not sit well with any service provider in the healthcare industry. As a result they are all planning to band together in opposition to this policy. Companies like Ubl are threatening to pull political endorsements and their campaign finance contributions if any antagonistic action is taken. While the opposition is concerned about their monetary detractions, the real issue lies with the price of life and how rising medication prices can be battled.

Without regulations, health care will either become too expensive for common man or cease to exist altogether. And while dealing with any other industry, the high risk-high profit game is not as dire or bittersweet. The risk of failure is higher in the biomedical industry than anywhere else because success directly correlates to saving of life, and failure directly correlates to medical death.