Posts Tagged: "drug pricing"

Yesterday, Representatives Carolyn Maloney (D-NY), Jerrold Nadler (D-NY) and David Cicilline (D-RI) asked Federal Trade Commission (FTC) Acting Chair Rebecca Kelly Slaughter to open a formal inquiry into pharmaceutical company AbbVie’s practices, which the representatives said have worked “to delay U.S. biosimilar entry for [AbbVie’s] blockbuster drug Humira.” The request was prompted by documents uncovered as part of an investigation being conducted by the House Committee on Oversight and Reform into the company. “Based on our review, these documents indicate that AbbVie delayed biosimilar competition for far longer than warranted by its own internal evaluations of the strength of its patent portfolio, which anticipated biosimilar entry no later than 2017,” said the letter.

The U.S. House of Representatives yesterday approved two bills meant to lower prescription drug prices and sent them on to President Joe Biden for approval. The Advancing Education on Biosimilars Act and the Ensuring Innovation Act were introduced by U.S. Senator Bill Cassidy, M.D. (R-LA) and broadly aim to improve the current market for cheaper generic drugs.

On January 12, the National Institute of Standards and Technology (NIST) published a request for comments on proposed changes to regulations that support the University and Small Business Patent Procedures Act of 1980, which is more commonly known as the Bayh-Dole Act. At the time, NIST explained that this important update to Bayh-Dole represents a key element of the Return on Investment Initiative, which seeks to maximize American innovation arising from the federal government’s more than $150 billion annual investment in research and development. Monday, April 5, was the deadline to submit comments to NIST on the proposed rule revisions. Below are a handful of excerpts to comments submitted, together with links to the full text of the comments.

One thing you should never say in 2020 is: “Well, at least things can’t get any worse.” They can and often do. The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. It’s also signed by 32 other state attorneys general, along with those representing the District of Columbia, Guam and American Samoa. They are demanding that the government use its authorities under the Bayh-Dole Act to march in against Gilead Sciences, the maker of the COVID-19-fighting drug remdesivir, so that it can be made more widely available at a lower cost.

In this age of polarization, it’s almost impossible to imagine Congress enacting bipartisan legislation that would benefit businesses, higher education, and consumers alike. But that is exactly what happened 40 years ago, and it is worth remembering. As has been outlined elsewhere on IPWatchdog in 1980, Democrat Senator Bayh and Republican Senator Dole wrote a bill that seemed simple, but changed the face of American innovation. Prior to the Bayh-Dole law, anyone who accepted government funding of their research had to give any resulting patent rights to the government. Superficially, that sounded fair – if taxpayer money paid for research, the taxpayer should get the benefits. But the reality was that no one benefitted. Few companies had any interest in investing the substantial resources necessary to transform an early invention into a product when the underlying patents were held and controlled exclusively by the government. And those inventions that were developed simply sat on the shelf in government offices with no plans to bring them to market. Senators Bayh and Dole recognized this problem and their bill allowed research institutions to keep possession of the patent rights their research produced.

The cost of medicines is on the agenda this week at the World Health Organization’s annual executive board meeting in Geneva. Nongovernmental organizations and certain middle-income countries argue that market-based drug development—reliant on intellectual property rights (IPRs) as its primary incentive—makes medicines too expensive. It fails, they say, to provide cures for those most in need but least able to pay. On the fringes of meetings such as the one happening this week, nongovernmental organizations talk excitedly about a new model for drug development, in which research and development (R&D) costs are “delinked” from the final prices of drugs. They join notables such as U.S. Senator Bernie Sanders and Nobel prize-winning economist Joseph Stiglitz. One of the main “delinkage” proposals is to replace the patent system with government-managed prizes.

A recent article by Dr. Kristina M. L. Acri née Lybecker highlighted her research about the fiscal workability of state pharmaceutical importation programs from two important aspects. Dr. Acri’s whole paper is very good. I recommend you read it if you’re into policy and not sound bites. I noticed, however, that the comments on the article elicited some common myths about Canadian drug importation that are important to address if we’re going to really understand this issue.

In mid-December, President Trump presented a plan to lower prescription drug prices by allowing states, drug wholesalers and pharmacies to import some cheaper drugs from Canada. While reducing the cost of medicines is a laudable goal, pharmaceutical importation programs – if implemented safely and effectively – would fail to deliver the promised savings. And if implemented without the necessary safeguards, they would endanger the lives of countless patients. The plan essentially relies upon importing price controls from Canada, which will both undermine innovation and prove unsustainable. As with many “simple solutions” the devil is in the details. Not surprisingly, the Trump Administration’s plan contains very few details on implementation. And it is precisely those details that are expensive and complicated.

Next year marks the 40th anniversary of the passage of the Bayh-Dole Act. With election day looming, 2020 is likely to be the most politically contentious year of our lifetime. The country is divided right down the middle on many fundamental issues. Rather than debate, the opposing sides often descend into personal attacks, even questioning one another’s patriotism. This isn’t the time you want issues you care about dragged into the public arena, but patent rights and the Bayh-Dole Act have been summoned into the gladiator pit. Happy birthday, indeed.

On September 13, U.S. Trade Representative Robert Lighthizer reportedly expressed a willingness to negotiate on several points of contention regarding the U.S.-Mexico-Canada Agreement (USMCA), including potentially reducing the 10-year period of intellectual property protection for biologic medicines. In response to this, the Pass USMCA Coalition is touting a memo penned by Former Department of Health and Human Services (HHS) Secretary Tommy Thompson aimed at “debunking the widespread myth that the USMCA will drive up drug prices.” Thompson, also a four-term governor of Wisconsin, now advises the Pass USMCA Coalition. Thompson’s memo focuses on three key arguments that he considers myths

Trying to rationally address hot button issues in an election year is always a dangerous proposition. That’s particularly true as we approach what promises to be one of the nastiest political years in history. Because so much time will be taken up campaigning, for legislation to pass it needs to get moving soon. It shouldn’t be long before we know whether anything meaningful will happen with attempts to reduce the costs of drugs, where intellectual property rights are in the crosshairs. Let’s keep our fingers crossed that, if action is taken, it’s based on careful consideration of all the related issues rather than raw emotion. While this may be wishful thinking, several thoughtful new articles contain important warnings against jumping down some of the beckoning gopher holes. Critics of the Bayh-Dole Act, which provides the incentives of the patent ownership to commercialize federally funded inventions, claim that the government is developing drugs from its R&D and giving them to companies that then make “obscene profits.”Despite numerous rebuttals, this red herring is continually deployed as the justification for the government setting the price of drugs coming out of public/private sector partnerships.

This week in Other Barks & Bites: The Trump Administration’s Final Rule that would have required list prices of drugs to be displayed in television ads is blocked by the U.S. District Court for the District of D.C.; the STRONGER Patents Act is reintroduced into both houses of Congress; the leadership of the Senate IP Subcommittee releases a statement on the splintered Federal Circuit en banc denial in Athena; the U.S. Copyright Office designates the mechanical licensing collective; Huawei is the top earner of Chinese patents thus far in 2019; Intel enters a period of exclusive talks in its wireless patent auction; T-Mobile and Sprint extend their merger deadline; Amazon launches initiative to retrain 100,000 employees for high-tech positions; and major drugmakers ask the Supreme Court to take up a patent case involving functional claiming issues.

In the face of pressure to pull provisions in the United States-Mexico-Canada Agreement (USMCA) that would grant 10 years of regulatory data protection (RDP) for biologics inventions, a recent report claims that the requirement would not result in higher drug prices for U.S. patients. The USMCA is currently being negotiated, but the chances of a vote this summer are quickly dwindling. In addition to other objections, many Democrats have opposed granting 10 years of RDP—an increase from 8 years in Canada and from 0 in Mexico (the U.S. period of exclusivity is longer, at 12)—arguing it would result in higher drug prices and delayed entry for biosimilars. Patrick Kilbride, Vice President of International Intellectual Property for the Global Intellectual Property Center (GIPC) at the U.S. Chamber of Commerce, has argued here before that the data does not support those claims.

This week, the U.S. Senate will hold hearings on enhancing drone innovation and addressing cybersecurity concerns; reducing prescription drug prices; and developments in geothermal energy technologies. The House of Representatives will host a hearing on clean energy tech development as well as a markup meeting on a proposed bill to increase participation in STEM careers. Meanwhile, think tanks the American Enterprise Institute and the Information Technology and Innovation Foundation will take a look at the patent reform debate with Representative Steve Stivers (R-OH) and explore the potential effects of proposed drug pricing reforms on innovation in the pharmaceutical sector, respectively.

Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue,  when Chairman  Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY)  that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee. However, because of two differences in this hearing from its predecessor things didn’t quite go as planned. This time, the Committee invited both sides to appear, not just the critics; and one member dared to challenge its underlying premise, leading to an electrifying exchange with the Chairman. We’ll examine that shortly.