Tag: companies
Where to Spend Your Healthcare Investment Dollars
In a blog entry written over the summer, I expressed the view that the next 5-10 years will present tremendous transactional opportunities in the life sciences/health care industry. Nothing has happened to dampen that view. In fact, President Obama’s reelection, which means that the Patient Protection and Affordable Care Act is here to stay and will be fully implemented over the next few years, and our ongoing deficit reduction concerns, mandate that efficiency, cost control and strategic ways to provide better quality healthcare will be at center stage. So let’s focus in on some investment opportunities that may be interesting.
For those willing to tackle regulatory and reimbursement hurdles, there should be many opportunities in the provider world. This could take the form of hospital mergers and consolidations, spin-off of various medical and lab services that have been provided at hospitals and … Read More »
Tougher Sanctions on Iran: What it Will Mean for Businesses
Tougher sanctions went into effect on October 9, 2012, that broadly expand the extraterritorial reach of the U.S. Government with regard to conducting business with Iran. Most significantly, with the Iran Threat Reduction and Syria Human Rights Act of 2012, any business owned or controlled by a U.S. parent may expose its parent to sanctions for its business activities with Iran.
Significantly, the new law allows for the imposition of civil penalties of up to $250,000, or twice the value of the transaction, for activities completed by any foreign entity owned or controlled by a U.S. parent, if such activities would violate U.S. sanctions laws if they were to be undertaken in the U.S. or completed by a US person. Stated another way, if a U.S.–owned or U.S.–controlled foreign entity enters into a transaction with an Iranian party that the parent … Read More »
House Bill Introduced on Clinical Trial Database Registry
On August 2nd, H.R. 6272, the “Trial and Experimental Studies Transparency (TEST) Act of 2012” was introduced in the House. TEST would amend the Public Health Service Act to expand the clinical trial registry data bank. Among other requirements, the bill would require all foreign clinical studies to meet the same requirements as domestic trials (if used to support an application for U.S. marketing).
Also, the bill would require that results from most covered trials be posted on the registry data bank within one year of the “primary completion date” of the trial. Delayed submission of results up to two years after trial completion would be allowed for trials on drugs of devices that have no previous history of approval for use. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) would be instructed to provide Congress … Read More »
Jesse Witten featured on Inside Counsel
On August 3, 2012, Jesse Witten published an article on his thoughts on Eucomed’s code of ethics.
To read the entire article, click here.
Tremendous Transactional Opportunities
For deal junkies, the next 5-10 years should be quite interesting in the life sciences/health care industry. We have already seen large pharmaceutical company consolidations, financial buyers investing in health care institutions and partnerships between payors and providers. And much of this before the Supreme Court decided that health care reform is here to stay.
What is driving this? Need, opportunity, cash and innovation. Pharmaceutical company brand drugs are losing their patent protection, the cost/risk of developing new drugs is enormous, heath care costs need to be controlled, people are living longer, health care reform is triggering new behaviors and strategies and, despite the difficult financial times, there is much cash available for investment. Also, much of the broader life sciences/health care industry has been slow in technology adoption, while technology and social media continues advancing, being available to a broader … Read More »
Massachusetts Amends Its Drug and Device Marketing Law
On July 8, Governor Deval Patrick signed a bill amending the Massachusetts law regulating marketing activities by pharmaceutical and device manufacturers, one of the strictest state laws in the country.
The law previously barred pharmaceutical and device manufacturers from providing meals to health care practitioners outside the practitioner’s office or hospital setting. See 111N Mass. Gen. Laws § 2. The amendment will now permit pharmaceutical and device manufacturers to provide modest meals and refreshments outside of the practitioner’s office or hospital setting, if the meal or refreshment is furnished with a non-CME educational presentation for the purpose of providing bona fide medical information, and the meal is furnished in a venue and manner conducive to communicating information. The amendment directs the Massachusetts Department of Public Health to promulgate regulations to define “modest meals and refreshments.” Pharmaceutical and device companies, however, will … Read More »
U.S. Supreme Court’s Affordable Care Act Decision: Impacts on Life Sciences
The June 28, 2012 U.S. Supreme Court decision upholding the Patient Protection and Affordable Care Act (“Act”) impacts the life sciences industry in a number of ways, including impacts on innovation and compliance initiatives by medical device, pharmaceutical, and biotechnology companies.
Innovation
A number of provisions in the Act provide incentives and resources for product innovation. First, it is expected that more than 30 million Americans will obtain health care coverage on account of the Act. A bigger pool of Americans with health coverage to pay for treatment will yield growth in pharmaceutical sales and, perhaps, the ability to charge higher drug prices, which, in turn, could spur innovation. In addition, the Act created the Therapeutic Discovery Project Program, through which $1 billion in new therapeutic discovery project grants and tax credits will be awarded. In 2010, 2,923 companies specializing in biotechnology … Read More »
Life Sciences – Just Another Way to Say “Intellectual Property”?
There is no corner of the American economy more deeply dependent on intellectual property rights than the life sciences. Of course, we all know that patents have long been central to the success of pharmaceutical and medical device manufacturers, and the unanimous decision in the Prometheus case this past month has brought additional scrutiny to a market segment often misunderstood in the popular press. That said, for players in the life sciences space, patents are only one of many ways that intellectual property shapes their business. In fact, the trademark, unfair competition and copyright laws can be just as critical, and a strategic understanding of their value can provide companies with real ownable distinction in the market.
What is a product with “ownable distinction?” It is the opposite of a generic commodity, and it is the holy grail in the life sciences. It … Read More »
The FTC Finally Issues its Report on Consumer Privacy
Interactive marketing is everywhere, and the Federal Trade Commission has struggled mightily over the past several years to deal with complex privacy issues that grow out of sophisticated, data-intensive marketing practices. On March 26, the FTC released its long-promised final report on consumer privacy. Critically, we now have a sense of the FTC staff position on future legislation, best practices and the secondary market in customer data.
The FTC was clear that it wants additional legislation to address general privacy concerns, data security and breach notifications. This is a change from the staff’s prior position that self-regulation would be sufficient, and lends weight to current efforts before congress to do exactly that (although the fact that we are currently in a highly partisan election year does diminish the likelihood of immediate action).
The rest of the report flowed logically from the principles … Read More »