FDA "increasingly concerned with the number of imported medical devices"...Made in the USA ???

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Important new recommendations have been issued by the US Food and Drug Administration (FDA) pertaining to medical device import entry review processes.
The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of their products into the US market. The letter and other detailed information about the FDA import review process is available on the FDA website.
"These recommendations will directly impact your company's ability to import medical devices, electronic product components, parts and finished products into the US," states the letter.
Specifically, the FDA recommends better adherence by importers to correct Affirmation of Compliance (AofC) data in order to avoid significant entry delays. An appendix of medical device AofC codes has been included with the FDA's Letter to Industry.
When a product enters the United States, medical device importers should make sure to include AofC codes for the following information:

• Device Foreign Manufacturer (DEV) or Device Foreign Exporter (DFE)
• Device Listing (LST)
• Device Initial Importer (DII)
• Premarket Notification (PMN) 510(k) number, if relevant
• Investigational Device Exemption (IDE)

The agency emphasizes that although use of AofC codes remains voluntary, firms that do make use of them greatly increase their chances of having their devices cleared for import entry faster.
A separate Letter to Industry focusing on the import entry filing process for medical devices that also qualify as electronic radiation products is forthcoming, according to the CDRH.
Any questions regarding the FDA’s import entry review process should be sent to the CDRH’s Office of Compliance Import/Export Safety Staff at cdrhocimport@fda.hhs.gov.

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New F.D.A.: Transparence and Flexibility

WASHINGTON — During the Bush administration, the Food and Drug Administration was mostly a place of black-and-white decisions. Drugs were approved for sale or they were not, and the agency’s staff was expected to publicly support those decisions.
But as Thursday’s landmark decision on the controversial diabetes medicineAvandia makes clear, things have changed under the Obama administration. Certainty, staff unanimity and even the approval status of big-selling medicines are no longer so black and white.
Presented with what seemed to be a choice between keeping Avandia on the market or withdrawing it, the Obama administration decided on an unusual middle path — allowing sales, but with tight restrictions. Even more unusually, the agency admitted that many of its top scientists disagreed, some passionately. Competing memorandums were posted immediately on the agency’s Web site.
And the agency’s three top officials co-wrote a highly unusual explanation of their action in The New England Journal of Medicine.
Some of these changes have been in the works for years, but they have accelerated under the Obama administration, driven by increasingly sophisticated measures of drug safety and growing skepticism about whether the F.D.A. is making the right decisions and making them appropriately.
“I think that F.D.A.’s credibility really depends on being able to explain its decisions well,” said Dr. Joshua Sharfstein, F.D.A.’s principal deputy commissioner. “We can’t expect people to think that F.D.A. has decided, therefore it’s the right answer.”
Some of the changes have been driven by people like Dr. Steven Nissen, a cardiologist at the Cleveland Clinic whose 2007 analysis of Avandia’s heart risks stunned doctors, patients and legislators, who asked why the F.D.A. had not done anything similar. When the agency revealed it had done an almost identical analysis a year earlier and found the same result, the controversy intensified.
“You have these third-party analysts setting the agenda for the agency in ways that never happened before,” said Daniel Carpenter, an F.D.A. historian at Harvard.
For the F.D.A., the Nissen analysis presented major challenges. It demonstrated that the agency no longer had a monopoly on the information needed to make drug and device safety decisions. Data from crucial clinical trials are increasingly being posted on public Web sites. And academics are using sophisticated techniques to test whether popular medicines are safe.
In March, for instance, a team of academics found that a children’s diarrhea vaccine contained harmless but apparently extraneous pieces of pig virus. Blindsided, the F.D.A. had no idea what effect the particles would have. While the agency studied the problem, the commissioner, Dr. Margaret Hamburg, asked its maker to stop selling — a request she had little power to enforce.
Two months later, the agency allowed sales to continue.
Like the vaccine finding, the Nissen analysis flummoxed the agency because the science behind it was controversial. Dr. Nissen combined the results of many clinical trials to suggest that Avandia substantially increased heart risks. Other studies suggested that there were higher risks.
None of these studies met the rigorous standards that the F.D.A. demands when approving new medicines, but they were among the only information available to explore whether popular medicines contribute to common problems like heart attacks.
The agency was torn about how to interpret the studies, a problem it rarely faced until recently. “In the past, we would approve the drug after a couple of efficacy trials and that was it,” Dr. Janet Woodcock, chief of the F.D.A.’s drug center, said in an interview. “We didn’t know too much more about the drug. It was simpler.”
Now, sophisticated analyses present the F.D.A. with a complex picture. “It’s good for public health that we’re learning more, but it creates a more complex environment in which to regulate,” Dr. Woodcock said.
It is an environment in which top agency officials are in some ways at sea. The agency has no systems or standards to follow in deciding which studies deserve their attention or should lead to changes in a drug’s status. And since new tests are being created constantly, creating such a standard would be an ever-evolving process.
Dr. Lynn Goldman, dean of the School of Public Health and Health Services at George Washington University, said the F.D.A. was being forced to become more comfortable with studies done in academic rather than regulatory settings. “They have to get used to a less controlled environment,” Dr. Goldman said.
And the agency’s decision to create a unique distribution program for Avandia is not one it can repeat often or doctors and pharmacists — who must learn a new system for each program — will give up.
“We have to get some standardization,” Dr. Woodcock said, “or we’ll burn out the system.”

Outsourced Big Pharma and Device Industry.......The Wild West of Blood, Yippee-I-aye!

The financial crisis of the past 18 months has put increasing pressure on drug and pharmaceutical companies to look more closely at their return on investment for R&D. This has led them to narrow the range of projects they believe will bring the best returns.
There has also been a change in the way these companies operate. About a third of the compounds they use now originate from outside the company, a figure that was previously close to zero.
"Within a few years, this could be as high as 70%," says Julian Remnant, director of life sciences for Deloitte. "They are finding the best science is coming from external laboratories."
In parallel, there is a huge push to look at the cost base of R&D. Pharma want these costs to be predictable, something that is hard to achieve when the research is carried out internally. Outsourcing, in contrast, can be done at a fixed cost.

Currently, blood products in China are totally divided into 9 categories from the type of product which is less than the developed countries. Besides, only several manufacturers can produce all the types at the same time. In recent years, the size of the market developed with an annual growth rate of 15%-20%. In 2007, the scale of China blood product market broke through 6 billion RMB Yuan mainly because of the annual growth of the human serum albumin market which takes 80% of China blood market. However, the demands of China blood product market can’t be well satisfied all along. An important reason is the short collection of the plasma raw materials caused by the policy factors. Domestic blood product manufacturers are small-scale enterprises basically, which has holdups including funds, technology, raw materials, and so on. Compared to the global blood product market, China has a very small proportion. However with the sustained economic development and the enormous population, China market has tremendous potential. 

Changing processes
Alongside this trend, the pharmaceutical industry is also in a state of flux as it shifts its base from chemical molecule-based products to biological ones, bringing with it different manufacturing techniques, a lot more clinical trials and an increase in costs that an industry already facing pressure to reduce prices is finding hard to sustain.
"There is a huge push to look at the cost base of R&D. Pharma want these costs to be predictable, hard to achieve when research is carried out internally."
This combination has led some companies to look at the option of outsourcing key functions to more cost-effective parts of the world, notably India, Southeast Asia and Latin America.
"The processes for biological trials are a lot more stringent," says Swetha Shantikumar, an analyst with Frost & Sullivan. "A lot more data needs to be gathered, and the costs of this are high in Europe or the USA. Yet there is cheaper manpower and similar facilities in some of the emerging markets."
On top of this, many common drugs will soon be reaching the end of their 20-year patent protection, and companies are hoping to jump in on this and start manufacturing them cheaply, a task that may prove too expensive in western countries. Add to that a desire for cheaper generic drugs and it is clear why some companies have looked to outsourcing.
"Healthcare costs are hitting the roof," says Shantikumar. "They want more generic drugs cheaper, so there is more pressure to outsource."
Patient pools
The governments of China and India are aware of this and are setting up facilities that are compliant to western standards to attract western drug companies, while the government in Brazil is setting up similar infrastructure so it too can get a share of the pie.
"India has the advantage that the gene pool of patients is very similar to the West, so clinical trial results will be similar," says Shantikumar. "This makes the approval process quicker."
The patient profile in some of these countries is wider than in the West, which can be an advantage for clinical trials. For example, China has a massive population and, particularly in rural areas, a lower standard of healthcare. This results in a large number of ill people and thus a ready audience for clinical trials.
It's a process that also benefits the Chinese people as the government is keen to set up more rural hospitals. Setting up combined facilities that can carry out clinical trials and act as local hospitals is seen as a way to let the West partly fund their creation.
"The financial crisis in the West has led to a lot of people heading back to their own countries."
"Western companies want to participate in the growth in healthcare in these markets," says Remnant. "There is also a lot of scientific talent in these markets."
The cost per patient for conducting clinical trials in these countries is significantly less than in the West. It is also seen as a long-term investment to be in growing markets for healthcare. Having facilities in these countries makes it easier for launching and selling products to their markets and in some cases regulations insist that the trials of drugs have to be carried out locally for the drug to be made available.
Developing countries are also able to capitalise on what is becoming known as the brain gain. Over the years, many of their top scientists and medical staff have been lured away from these countries by the higher earning potential of the West. Setting up research laboratories and more medical facilities on home soil is encouraging some to return to their countries.
"They are coming back and bringing knowledge with them," says Shantikumar. "Also, the financial crisis in the West has led to a lot of people heading back to their own countries."
IP and compliance
One big drawback for international companies, notably China, has been IP protection. Counterfeiting of almost every product has been a major problem in many Southeast Asian countries and has put off international companies from investing in these areas. But the situation is improving and the Chinese government in particular is making big strides to tackle this issue.
"The government wants to improve the situation so foreigners will be comfortable in investing," says Shantikumar. "Previously, there were a lot of security issues. The Indian IP system is stronger than China's but both are trying to improve."
"China has a massive population and a lower standard of healthcare. This results in a ready audience for clinical trials."
India has a language advantage over China when it comes to attracting western companies because far more of its population speak English.
A disadvantage for all these emerging outsourcing locations is that physicians are not as familiar with the clinical trial process as they are in the West, but that situation is improving.
"There are also disadvantages because of lax regulations," says Aparna Krishnan, senior research analyst at IHS Global Insight. "If they work with local industry, there is a danger of supplies being contaminated because standards are not adopted. This is the main worry. It makes more sense for them to set up their own facilities so they can maintain standards."
Remnant agrees: "There are quality issues. The level of compliance is not as high as in the West."

EU Lacks Transparency In Adverse Event Reports

The regulatory considerations for the US are often cited as so rigorous that they delay valued technologies reaching the market. However weak EU vigilance and a systemic vision for EUDAMED lacking transparency earmarks all EU individuals as easy victims for massive medical device testing and product failure.
In todays world of outsourcing of Medical Device production to manufacturing wild west territories such as India and China concerns should be creating a greater need for vigilance and freedom of public access. And yet Eudamed state:

Who can access Eudamed?

Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission and is not publicly accessible. Eudamed is currently being used by a number of Member States on a voluntary basis and will be obligatory as from May 2011.

However the public are not to be informed, it would seem reasonable for a patient or physician to have available adverse event reports (proven or not). It seems EU citizens will not have this visibility.......WHY???
Fundamentally the EU lacks transparency for both patients and physicians in terms of adverse event reports, it also lacks clearly defined regulation of notified bodies and along with this does not indicate clear packaging notification of origin of country production. A company registered anywhere in the world may not be required to specify their product is produced, packaged and sent from India, China or Timbuktu. 

All of this also begs the question of "What events happen in Mexico, Yemen and beyond?". The case for Global Harmonisation is an issue often discussed but will ultimately be driven by a disaster.

The following Belgian Document (French initially, but English follows) highlights major concerns.