Posts Tagged: "drug pricing"

On May 12, Frederick Reinhart published an article titled “Knowledge Ecology International Letter Misleads on March-In Rights.” Reinhart is a past president of the Association of University Technology Managers (AUTM), and his views echo those expressed by many in the university technology transfer field, including a frustration that not everyone acknowledges and appreciates the considerable investments and risks undertaken by the for-profit companies that license patents to inventions funded by the federal government. Knowledge Ecology International (KEI) recognizes the importance of the private sector in bringing therapies to the market, even when federal funding of R&D has played a role, and also that robust returns on those investments have a positive impact on innovation.

Is Congress really going to do anything useful with respect to lowering drug prices? When the question is presented that way the answer almost seems painfully obvious. Of course not. The question is just how bad they will mess things up, and will they destroy the incentive to innovate as they attempt to seek a very worthwhile solution for the problem of growing costs for healthcare. Unfortunately, the political climate in the United States has increasingly become more circus and circumspect than bold and visionary. It is better to do something entertaining and memorable that plays to the crowd than to go about the business of governing the country, not just for the moment, but for the future. And the political structures in place create outright gerrymandering that practically ensure the overwhelming percentage of Representatives have more to fear from a primary challenge than from a contender in the general election. It is no wonder nothing truly useful can get accomplished in Washington, DC.

High prescription drug prices and their impact on costs borne by the government in Medicaid, Medicare Part D and other federal programs, is a front burner topic in Washington. The President has committed to reducing the price of prescription drugs, and pressured drug companies to hold the line. The Department of Health and Human Services (HHS) has proposed two regulatory initiatives—price disclosure in drug advertising and foreclosing rebates from manufacturers to pharmacy benefits managers (PBMs)—aimed at pushing prices down. Some Democrats have urged more sweeping actions, such as having the government negotiate Medicare drug pricing as a single buyer or regulating drug prices by reference to an international index based on government-negotiated drug prices abroad. These proposals cannot solve the drug pricing problem. The Administration’s proposals merely tweak the status quo and put no effective restraint on new drug prices. Jawboning by the Executive has had a minimal impact. Disclosure of manufacturers’ list prices, unless accompanied by numerous and inherently confusing caveats highlighting the difference between those prices and the co-pay an insured consumer must bear at retail, is potentially misleading and, in any event, has no direct impact on prices. Eliminating rebates, as HHS’s rulemaking acknowledged, will inevitably raise health insurance costs now partly paid for by rebates while manufacturers’ pricing power remains unabated. The Democrats’ call for government power buying or price regulation would impact drug prices but also require politically sensitive government determinations about the “worth” of prescription drugs to patients—a significant step on the road to government-allocated health care. 

The Senate has a busy schedule related to tech and innovation topics for the week of April 8, including hearings on prescription drug pricing, broadband Internet coverage maps developed by the U.S. government, free speech on social media and tech platforms, and clean energy innovations to address climate change. The Senate Environment Committee also has a business meeting this week to discuss a piece of legislation that would support innovation in direct air carbon capture. This week’s tech and innovation lineup at the House of Representatives is a bit lighter, although there are hearings looking at a proposed bill to restore net neutrality, as well as a review of the 2020 budget request for the National Institute of Standards and Technology. Elsewhere, the Brookings Institution hosts events on EU-U.S. digital data collaboration and the impact of automation on the future of work, and the Information Technology and Innovation Foundation explores funding issues for the National Institutes of Health and their impact on American biomedical innovation.

This week on Capitol Hill will include a series of hearings related to tech and innovation topics on Tuesday at the House of Representatives, where debate will focus on the 2020 budget for NASA and the National Institutes of Health, as well as on technology issues at Veterans Affairs. Senate hearings will take a look at Alzheimer’s research and funding for the Department of Energy. On Wednesday, the Senate IP Subcommittee will hold a hearing to look at gender diversity issues in the U.S. patent system. Elsewhere in D.C., the Cato Institute will look at Medicare drug pricing issues, a topic which has increasingly included discussion of patents, and the American Enterprise Institute will consider consumer data privacy issues in a two-hour event featuring officials from the Federal Trade Commission and Department of Justice.

This week on Capitol Hill, both houses of Congress are abuzz with a full schedule of hearings related to science, technology and innovation topics. In the House of Representatives, various committees explore a proposed net neutrality bill, innovation in the aviation industry, and ways to improve competition in the pharmaceutical industry—a hot topic of debate in recent weeks. Both the House and the Senate will hold hearings on the future of America’s space program. The Senate will also consider consumer data privacy regulations, rural broadband investments, and military applications of artificial intelligence. On Tuesday, a pair of events at the Brookings Institution will look at the impact of technological advances on public policy, as well as the artificial intelligence race between the U.S. and China.

This week on Capitol Hill and in the Washington D.C. area, the Supreme Court grants cert in Iancu v. NantKwest; the U.S. House of Representatives will hold several hearings on important topics in technology, including electronic health records modernization for veterans, cybersecurity measures for voting systems and research on the nexus between energy and water. House committees will also explore ways to improve broadband access for small businesses and promote generic competition to reduce branded pharmaceutical prices. Drug pricing, which often involves a focus on patents, is the subject of a two-part hearing series in the U.S. Senate. Other Senate hearings this week will look at data breaches in the private sector and IP issues related to Chinese trade. The week is book-ended by a pair of events hosted by the Information Technology & Innovation Foundation, including a Thursday event that looks at the impact of the Bayh-Dole Act of 1980 and controversial calls to enforce certain provisions of the law to reduce drug prices.

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure prophylactic (PrEP) treatment to reduce the risk of contracting human immunodeficiency virus (HIV) in sexually active individuals. Recently, this HIV PrEP treatment and its patent have been thrust into the spotlight thanks to a commercial for Truvada that Gilead ran during the January 27 broadcast of Rent: Live on the Fox television network. While many were encouraged by the fact that a national TV network was raising awareness about PrEP treatment, the commercial sparked a return to a debate over the high price of Truvada. As of June 2018, news reports indicated that once-daily Truvada treatment cost about $1,500 per month, or around $18,000 per year. Although the cost of Truvada is often covered by health insurance, the treatment hasn’t been adopted as widely as was expected when the drug was approved. Between January 2012 and March 2014, a review of half of U.S. pharmacies by Gilead showed that only 3,253 had begun a PrEP regimen during that time, far less than the estimated 500,000 people who would make good candidates for Truvada. That number has expanded rapidly to 77,120 U.S. PrEP users in 2016 and an estimated 136,000 users by the end of 2017’s first quarter, but that’s still far short of the estimated 1.2 million American adults at high risk of HIV infection who could benefit from PrEP. “Based on feedback from partners and our work in the field, we believe that one of the greatest barriers to Truvada for PrEP access today is limited awareness of Truvada for PrEP’s role in HIV prevention,” Gilead told IPWatchdog. “Data from our patient support programs do not suggest that cost is a primary obstacle to treatment. The majority of people receiving Truvada for PrEP today who utilize our co-pay coupons pay less than $5 per bottle.”

This week on Capitol Hill, the newly revived Senate Subcommittee on Intellectual Property meets for the first time this term to discuss the 2019 “Annual Intellectual Property Report to Congress”; other Senate committee hearings will look at concerns related to drug pricing, the effects of the Made in China 2025 initiative on American industry and proposed legislation to support innovation in carbon capture technologies; U.S. House of Representatives committees hold hearings focusing on issues from cybersecurity in the nation’s surface transportation and defense agency to energy research funding programs and trade tensions between the U.S. and China; and elsewhere in the nation’s capital, the Heritage Foundation looks at issues related to the modernization of the United States’ nuclear submarine fleet and the Cato Institute holds a day-long event on Friday to examine the topic of regulating the activities of American tech giants like Facebook and Amazon.

Last month, business news outlets were reporting that stock prices for pharmaceutical firms Pfizer and Merck took a tumble after financial analysts downgraded the performance of both firms over concerns about impending patent cliffs or exclusivity issues – although more recent reports paint a mostly promising picture for the companies, thanks to upcoming acquisitions. A pharmaceutical analyst for UBS downgraded Pfizer from buy to neutral, citing the loss of patent protection in the 2025 to 2029 timeframe for several drugs which contributed 30 percent of Pfizer’s total revenue in 2015. For Merck, although patent expiry wasn’t cited in a note from a pharmaceutical analyst from BMO, that analyst dropped Merck’s rating from outperform to market perform based on the expectation that the company’s blockbuster cancer drug Keytruda would face increased competition in the immuno-oncology field during 2019. As of January 30, stock prices for both firms were down by at least a dollar per share from their closing price on January 23. The downgrades for both firms are further proof of the importance of maintaining exclusivity through patent protection to pharmaceutical firms.

This week is quiet on Capitol Hill with Presidents’ Day on Monday, after which the House of Representatives enters a district work period and the Senate is out of session for the rest of the week. However, Washington, D.C., will still host a series of events related to intellectual property, innovation, and technology. Counsel and amici appearing before the U.S. Supreme Court in Mission Product Holdings Inc. v. Tempnology, LLC on Tuesday will offer post-oral argument reflections this Wednesday at the American University Washington College of Law. Earlier that same day, the Information Technology & Innovation Foundation looks at the policy debate surrounding the U.S. Postal Service in the e-commerce era. This week in IP, business and tech policy wraps up on Thursday with a look at lunar tech commercialization and other legal matters related to Moon exploration by the Washington Space Business Roundtable.

The opening salvo in what promises to be one of the hottest debates in the new Congress was fired January 29 during a day-long hearing in the House Committee on Oversight and Reform—how to lower the price of prescription drugs. And it didn’t take long to make it clear that patents are right in the middle of the scrum. The role of patents was a prominent part of the House hearing. While cursory nods were made to the importance of encouraging innovation, the witnesses discussed how patent exclusivity, thickets, and evergreening drove up prices while promoting the greater use of Patent Trial and Appeal Board (PTAB) reviews against drug patents. The Committee was assured that curtailing patents wouldn’t harm innovation because the National Institutes of Health (NIH) is such an important funder of life science R&D.