Drug Development Clinical Trial Data – Public or Private?

Posted by Judi Space on Thu,Jan 23, 2014 @ 06:00 PM

Should drug development information from clinical trials be made public or kept private? In the past, data from clinical trials of new drugs and medical devices have been the property of the companies that designed them, and they were allowed to control how and what data was released. The FDA and international equivalents research new products before granting approval, so data the company generated during drug development was up to the company to disseminate as it wished. Now, with the widely held perception that companies have only been releasing results that favored their products, the pendulum is swinging toward regulation making all data on approved drugs and devices available to the public.

The Transparency Campaigners

In Britain, the transparency initiative has been headed by the British Medical Journal, which now requires all authors of drug or device clinical trials who publish in the Journal to provide full scientific study data to anyone with a reasonable request. Also, the Cochrane Collaboration (an international non-profit) began campaigning for increased transparency when it was attempting to verify the efficacy of TamiFlu and was unsatisfied with the available data. 

These major players are joined by doctors, researchers, medical journals, and scientific societies who advocate more transparency in publishing detailed results of clinical trials and as much data about the specifics of the trials as possible. They have been pressing for this data not only going forward, but also for all medicines currently on the market.

The Drug Regulators: EU, EMA, FDA

In December 2013, the EU drafted a clinical trials regulation that will require clinical trials to be registered and results uploaded to a database that can be accessed by the public. This legislation is expected to be formally approved this year. Also, the Public Accounts Committee (of British Parliament), has issued a report this monththat calls for “full methods and results” to be released from all clinical trials, future and past.

Meanwhile, the European Medicines Agency (EMA), which is the European equivalent of the FDA, is considering a new policy on proactive disclosure of trial results, but further discussion of the issue has been tabled until March. Last year, The EMA received injunctions from both AbbVie and InterMune received injunctions against the EMA to prevent it from releasing trial data to competitors, but these injunctions were lifted last month.

In the United States, basic results of all clinical trials must now be registered in a national database that is accessible to the public (www.clinicaltrials.gov). The FDA also publishes staff reviews and other documents when it approves a new drug. However, federal laws restrict what kinds of information can be released, especially data that could reveal personal or commercially confidential information.

Self-regulation by the Pharmaceutical Industry

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) are fighting back by drawing up “principles for responsible data sharing” for pharmaceutical companies to voluntarily abide by. Some companies have already promised to release years of detailed clinical data upon request, in response to public relations issues.

The ABPI (Association of the British Pharmaceutical Industry) has pointed out that a peer-reviewed study it commissioned in 2013 showed a “positive trend” of increasing levels of disclosure – almost nine out of ten of all industry-sponsored trials were disclosed as of January 31, 2013.

Balancing Economic Interests with the Public’s “Right to Know”

PhRMA has argued that proposals for mandates to release all trial information go too far. “If you dump onto the sidewalk all the data, and you include commercially protected information,” he said, “then you’re essentially giving to competitors what we invested billions of dollars in.”

PhARMA claims that if the medical research industry is forced to disclose data that allows competitors to replicate their products, companies will be deterred from developing new drugs and devices that could improve quality of life for many people. On the other hand, patent protection prevents this kind of product replication. At the same time, publication bias can be used by unscrupulous members of the industry to mislead the public.

When the EFPIA/PhRMA pact was announced last year, EFPIA acknowledged that the industry was slow in affecting change. Given the exposure this topic has received recently, efforts to self-regulate may be too late to affect the groundswell of opinion in favor of legislating more transparency in drug development.

This post is based on an article by Ian Schofield – “The rising tide of trial transparency.” 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: FDA, Drug Developers, EMA, Drug Development, Clinical Drug Trials

Momentum for Biosimilars is Building. What’s Next?

Posted by Tom Penrice on Tue,Apr 23, 2013 @ 06:00 PM

Overview:
Both the FDA and the EMA are showing increasing levels of support for biosimilars, while physician resistance is declining in both the US and Europe. Cost is a big driver, among other factors.[1]

Biosimilar Drug Development Trends in Europe – Timing is Everything

Biosimilar drug development trends in US and European pharma drug development industryResistance to biosimilars in Europe is declining just as patents are expiring on many highly lucrative biologics, among them Herceptin (trastuzumab), Remicade (infliximab), and Rituxan (rituximab).  Significant cost advantages, important regulatory changes, and a growing openness to new methods of scientific analysis have combined to drive the trend.  Although the financial performance of biosimilars has been disappointing to date, nevertheless the perceived opportunities are attracting innovators and new players.

Why the Resistance to Lower Cost Biosimilars?

Resistance to date has been due primarily to two factors: pushback from physicians reluctant to switch patients to a biosimilar drug, and the lack of a systematic way for pharmacists to easily substitute a biosimilar for an originator drug.  As a result, the returns from biosimilars in Europe have been unimpressive to date. 

Meanwhile, in the US the FDA has yet to receive its first biosimilar application, despite the fact that for two years a regulatory pathway has been provided.  Innovator lobbying at the state level is a major factor contributing to the quagmire, whereby bills are being pushed to make it more difficult for automatic substitution of biosimilars for branded biologics to take place.

Doctors Signing On – Slowly

Unlike the FDA in America which has decision making power for all 50 states for such issues,  the EMA must leave it to each national government to make their own rulings on biosimilars.

In Norway, physicians are slowly growing more positive toward biosimilars partly due to price, a growing factor given sluggish European economies and rising health care costs, according to a cardiologist and medical director at Norway’s regulatory agency.

Economic incentives to prescribe cheaper drugs are also affecting physician acceptance of biosimilars in some northern European countries. For example, in Germany prescription quotas for generic drugs are imposed on physicians as a way to keep within allocated budgets. It is also helpful that Germany has declared copycat EPO’s to be the equivalent of the originals. Although not legally binding, these quotas in Germany have contributed to copycat EPO penetration growing from 30% to 39% in the past three years.[2]

Biosimilars - Impact on Price and Profits

The downward pressure on price due to the growing adoption of biosimilars has resulted in innovators making deep price cuts in order to retain market share, including with hospitals. As a result, payers are enjoying the savings.  Savings in Germany are estimated at over €1 billion per year by 2017.

Changing Definitions and Perceptions

EMA is increasingly accepting biosimilars due in part to recognizing that analytical science gains have made it possible to supply proof of similarity without requiring the time and expense of clinical data.  Last year EMU changed it’s description of biosimilars from products deemed “similar but not identical” to one stating, “the active substance of a biosimilar and the reference medicine is essentially the same biologic substance, though there may be minor differences”, thereby making it more difficult for innovators to make the case for their originals. 

FDA More Open to Biosimilars?

The FDA, while arriving late to the game, may be more open to biosimilars than EMA in terms of an easier acceptance of the analytical science argument for determining similarity. By comparison, the EMA appears to rely more on a clinical trial mindset. The US approach has not been without its rewards, as competition and savings can be significant. According to IMS Health, the US health care system has saved $1.6 billion since launch on Sandoz / Momenta Pharmaceuticals Inc.’s m-enoxaparin, the first of two competing complex copies of Sanofi’s Lovenox (enoxaparin).

Long Term Impact of Biosimilars on the Pharma & Biotech Industry

Now that payers are alert to the cost savings potential of biosimilars, there can be little doubt that the pressure to drive down prices will continue unabated. Indeed, the payers, especially the government payers, have the capability to change the game very quickly.

If prices and profits were to drop sharply and frequently for originals due to growing inroads made by biosimilars, one must wonder to what degree investment in research by innovators may suffer.


[2] http://www.elsevierbi.com/publications/the-pink-sheet/75/6/germany-may-need-to-jump-start-its-stagnant-biosimilars-market 


Pennside Partners is a leading pharmaceutical and biotech consulting firm with over 25 years experience. They are headquartered in the United States, the United Kingdom and Switzerland.

Tags: Pharma Brand Strategy, FDA, Drug Developers, Biosimilars, Health Care Costs, EMA

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