Tag: "Pharmaceuticals"

Blurring Boundaries Between Biotech, Digital Health, Patient Care Show Need For Regulatory Reform

HSA(A version of this Health Alert was published by Forbes on July 29, 2015.)

When was the last time a billionaire entrepreneur en route to New York to raise a couple of hundred million dollars for biotech company stopped in Washington, DC to spend the afternoon in a panel discussion advocating the need for fundamental reform of the Food and Drug Administration?

Patrick Soon-Shiong, MD, founder of the NantWorks group pf companies, did just that on Monday afternoon. At the event, the Bipartisan Policy Center launched a report on advancing medical innovation in America. Written by a team led by former U.S. Senate Majority Leader Bill Frist, MD, and former Representative Bart Gordon, the report seeks support for a number of steps to reform regulatory processes and reduce the cost of medical innovation.

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Jul 29, 2015 | Leave a Comment | by

Regulating Genomic Research: Top-Down or Bottom-Up?

iStock_000012644846Small(A version of this Health Alert was published by Forbes on 7/27/2015.)

The next frontier in information technology is genomic sequencing, which will create the biggest of big data resources by 2025, according to experts in the field. It has been 15 years since President Clinton announced the first sequencing of the human genome; and it is now clear that researchers’ ability to free the unimaginable wealth of information locked inside our genomes is bumping up against constraints imposed largely by the federal government.

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Jul 27, 2015 | Leave a Comment | by

21st Century Cures Act Passes House with Overwhelming Bipartisan Support

This morning, the U.S. House of Representatives passed (344-77) the 21st Century Cures Act. This is a monumental achievement, designed to fundamentally restructure the Food and Drug Administration and thereby reverse the staggering decline of productivity in medical research and development.

The bill started as a bipartisan effort in the House Energy & Commerce Committee, where Republican and Democratic leaders moved beyond rhetoric and went right back to the basics, questioning the role of the federal government in spurring innovation and regulating our access to medical technology.

Unfortunately, their achievement is tainted by another fiscal glitch. For the third time (after the Medicare “doc fix” and repeal of the medical device excise tax), the House has voted for spending while weakening its commitment to offsetting cuts.

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Jul 10, 2015 | 1 comment | by

Caution: 21st Century Cures Act Has A Suspicious Payment Plan

prescription-drugs(A version of this Health Alert was published by Investors Business Daily.)

The House of Representatives is scheduled this week to consider the 21st Century Cures Act (H.R. 6), a health policy bill designed to improve the economic incentives and streamline the process for inventing new medicines.

We applaud the act. It will go a long way to solving the crisis in pharmaceutical innovation. But we caution against the mandatory funding proposal in the bill and urge Congress to authorize and appropriate the funds instead of creating a new, mandatory spending program.

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Jul 08, 2015 | Leave a Comment | by

Trans-Pacific Partnership: Intellectual Property Rights Won’t be Strong Enough

A few days ago, I discussed my concern that intellectual property rights for pharmaceutical innovators would not be strong enough in the Trans-Pacific Partnership agreement for which President Obama seeks Trade Promotion Authority.

Well, they won’t be strong enough, according to information leaked from the negotiations:

Facing resistance from Pacific trading partners, the Obama administration is no longer demanding protection for pharmaceutical prices under the 12-nation Trans-Pacific Partnership, according to a newly leaked section of the proposed trade accord.

But Pacific accord negotiators appear ready to grant pharmaceutical and medical device makers more power to influence participating governments. The 12 countries involved, and any others that might join later, would have to disclose rules and guidelines for deciding which medical products would be made available through government programs and at what rate providers would be reimbursed.

(Jonathan Weisman, “U.S. Shifts Stance on Drug Pricing in Pacific Trade Pact Talks, Document Reveals,” New York Times, June 10, 2015)

Call me old-fashioned, but I think that’s a pretty reasonable request.

Jun 11, 2015 | Leave a Comment | by

Trans-Pacific Partnership: Will Intellectual Property Rights Be Strong Enough?

Having passed the Senate, it is now up to the House of Representatives to decide whether to give President Obama Trade Promotion Authority (TPA, or “fast track”) to negotiate the Trans-Pacific Partnership.

Most Congressional Republicans who support TPA also advocate strong intellectual property rights. However, one concern with TPA is that it is uncertain the President will negotiate strong intellectual property rights in the TPP. What will these Republicans do if the final version of the TPP does not have adequate protection for investment in intellectual property?

One example is the protection of data exclusivity for inventors of new biotech products. The U.S. has the gold standard – 12 years – and it is reasonable to seek this standard in the TPP.

When it comes to pharmaceutical patents, U.S. Senator Orrin Hatch is on the side of protection intellectual property with respect to current trading partners. He recently criticized the president for not doing enough to pressure India (which is not in the TPP) to improve its patent protection.

On the other hand, he was the Senate champion for fast track for TPP. Is this consistent?

Jun 09, 2015 | Leave a Comment | by

Obamacare Patients Had Lower Drug Spending Than Patients In Employer Plans

A scholarly study of data from America’s largest pharmacy benefits manager concludes that Obamacare beneficiaries had lower drug spending than people in employer-based plans:

We used data from January–September 2014 on more than one million Marketplace enrollees from Express Scripts, the largest pharmacy benefit management company in the United States. We compared the characteristics and medication use between early and late Marketplace enrollees and between all Marketplace enrollees and enrollees with employer-sponsored insurance. Among Marketplace enrollees, we found that those who enrolled earlier (October 2013–February 2014) were older and used more medication than later enrollees. Marketplace enrollees, as a whole, had lower average drug spending and were less likely to use most medication classes than the employer-sponsored comparison group. However, Marketplace enrollees were more likely to use medicines for hepatitis C and particularly for HIV.

These are startling findings, and even contrary to earlier releases from Express Scripts itself. It does not seem consistent with emerging evidence that insurers are jacking up their Obamacare rates for 2016 because of higher than expected claims experience.

Jun 01, 2015 | 2 comments | by

High U.S. Health Prices From “Market Power”?

The National Academy of Social Insurance (NASI) recently published a consensus report on provider consolidation. Basically, we have a growing problem in that hospitals are buying each other up and also physician practices, which leads to reduced competition and higher prices.

The report was promoted with an op-ed in The Hill by the esteemed Robert A. Berenson (Urban Institute) and G. William Hoagland (Bipartisan Policy Center):

The use of market power—or the ability to raise and keep prices higher than would prevail in a competitive market – is the key reason the United States spends so much more on healthcare than other countries.
For policymakers, tackling the lack of competition is like climbing a mountain. Even the initial steps — creating more competition – may be difficult, but they must be explored before more regulatory action further down the path is considered.

These are remarkable statements; and difficult to accept uncritically.

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May 21, 2015 | 2 comments | by

Financing Breakthrough Medicine: Opportunities and Obstacles

(A version of this Health Alert was published by Forbes.)

Variety of Medicine in Pill BottlesResearchers at RAND Corporation have given a clear and precise description of a new financing mechanism for medical breakthroughs. The proposal would address a problem recognized about a year and a half ago, when healthcare payers launched high-profile complaints about the price of Sovaldi®, a miracle drug that effectively cures a strain of Hepatitis C.

In a nutshell, the problem is that Sovaldi® costs up to $84,000 per course, administered over a short period of 12 to 24 weeks. However, its benefits are lifelong: Hepatitis C patients live for decades with diseased livers. Transplantation is a $300,000 procedure followed by expensive drugs to prevent rejection of the new liver. However, payers with annual budgets do not have adequate incentives to pay in one year for savings that accrue over decades.

Sovaldi® was quickly followed by another Hepatitis C wonder drug, Harvoni®. More generally, the previous generation of blockbusters (now mostly generic) were targeted at chronic conditions like high blood cholesterol. Drugs designed to be taken regularly over many years demand a different pricing model than those designed to be taken only for a short period and lead to a clean cure.

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May 06, 2015 | 10 comments | by

Intellectual Property Rights for Global Health

(A version of this Health Alert was published by Forbes.)

patent-pendingRepublican congressional leaders are eager to give President Obama Trade Promotion Authority, or “Fast Track.” Proponents argue that Fast Track will break the logjam holding up important international trade agreements like the Trans Pacific Partnership (TPP), which includes countries as diverse as Australia, Canada, Peru and Vietnam.

Fast Track would allow the president to finalize the agreement before sending it to Congress for a straightforward up-or-down vote within a limited time. However, the likelihood of Fast Track resulting in TPP getting a “thumbs up” from Congress is limited by potential differences between the president and the congressional majority on intellectual property rights.

In a recent Wall Street Journal op-ed, Representative Paul Ryan (R-WI) and Senator Ted Cruz (R-TX) asserted that the administration must pursue a number of negotiating objectives, including “beefing up protections for U.S. intellectual property” if it wants Congress to approve the TPP.

It is uncertain the president is as committed to intellectual property as Mr. Ryan and Mr. Cruz hope, especially with respect to patents for medicines. Although the text of the TPP is not yet available to the public, the U.S. Trade Representative, who negotiates in the president’s name, insists that “TPP countries have agreed to reflect in the text a shared commitment to the Doha Declaration on TRIPS and Public Health.”

The 2001 Doha Declaration was an attempt to limit international trade agreements’ commitment to patent rights that were accepted in the World Trade Organization’s 1995 Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement. It insists that low and middle-income countries should have broad latitude to allow generic drug makers to make copies of patented medicines through a legal mechanism called “compulsory licensing.”

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Apr 29, 2015 | 2 comments | by
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