1. Rx-360 is an international
pharmaceutical supply chain consortium dedicated to protecting patient safety.
Please explain Rx-360’s strategies, mission, and activities to our readers.
Rx-360’s mission is to promote
patient safety by sharing information and developing processes to improve the
integrity of healthcare supply chains and the quality of materials moving in
those supply chains. To meet this mission, Rx-360 has pioneered a joint audit
program for upstream suppliers, downstream distributors and others that are
engaged in moving materials and products in commerce that must be properly
qualified by manufacturers. In doing so, we manage audits of raw materials and
basic chemicals, packaging materials, excipients, active pharmaceutical
ingredients, wholesalers and common carriers by multiple sponsors who are each
blinded from each other. In this way, we can lower the cost of the audits to
each sponsoring manufacturer while simultaneously reducing the increasing audit
burden on their trading partners.
In addition to the joint audit
program, we have developed multiple white papers covering best practices for
securing the integrity over the entirety of supply chains. We do this through
internal work groups that are comprised of subject matter experts from our
member companies. They have done a terrific job covering a myriad of programs
and at any given time, we may have up to 15 active work groups operating at
various stages.
2. Your function and audit programs
you offer are not only important for the patients but also for pharmaceutical
companies as well. Can you explain about the benefits pharmaceutical companies
would receive from working with Rx-360?
As noted above, the pharma companies
benefit by sharing the costs of audits performed uncommon suppliers. They also
are blinded from each other when they do so, so we can alleviate
anti-competitive concerns that may otherwise exist. And since we use a single
audit firm - British Standards Institution - the audits tend to be consistent
and importantly, our footprint is global. We perform audits wherever the
suppliers exist. In addition, once an audit report is finalized, we make them
available for purchase by third-party firms that did not participate in the
audit. Those revenues are then used to provide credits to the original
sponsoring firms for that will offset the costs of future audits they need to
perform up to 100% of their original audit cost. While there are clear benefits
to finished product manufacturers, the benefits to the suppliers that are
audited can be even more extensive. For suppliers that sell components and
other materials to pharmaceutical and medical device companies, they are
frequently under substantial pressure to allow audits to their customers as
part of the customers’ required vendor qualification programs. For suppliers
that have hundreds of customers at a given site, the burden of audit requests
is truly unsustainable. Consequently, our joint audit program helps alleviate
that burden. Finally, under the new EU rules requiring manufacturers to qualify
wholesalers and common carriers before distributing their products, those firms
provide services to literally thousands of manufacturers. Therefore, they will
absolutely require a joint audit firm like ours, along with a very robust
licensing program to third parties, since they simply cannot and will not be
able to withstand the avalanche of audit requests coming their way.
3. We see that Rx-360 has partnered
with BSI Supply Chain Solutions to lead its international joint audit program.
Why are international business important and what benefits will companies
overseas gain from working with Rx-360? Also, how many members do you currently
have globally?
First, let me address the membership
question. Currently, Rx-360 has about 65 members in the EU, USA, China, Japan,
and India. We are really hoping that companies in Korea will join us. Our
members are generic, branded, small and large. They are finished product
manufacturers and suppliers to those manufacturers. We also have several
software and related companies that provide support services to all our
manufacturing members. The goal is to do what we can to promote patient safety.
Our membership fees are very small by trade association standards and it gives
employees of both small and large members to participate equally so that
solutions can be developed that are pragmatic and meet everyone’s needs -
particularly the patients we are honored to serve.
Second, regarding the utilization of
British Standards Institution (BSI) as a sole provider of audit services, they
have a proven record on a global basis. They are well-known to regulatory
authorities and, on the medical device side, are a notified body in the EU and
are a third-party accredited audit firm by the US FDA Center for Devices and Radiological
Health (CDRH) as part of CDRH’s Medical Device Single Audit Program (MDSAP). In
those capacities, BSI serves as “co-regulators” and its practices are routinely
subject to regulatory inspections. Hence, we have great confidence in their
abilities. It’s also worth noting that BSI - the parent company of the BSI
Supply Chain Solutions - is, like Rx-360 - a nonprofit, so they understand that
aspect of our organization and what we are trying to do for the industry. That
said, please also note that when Rx-360 initiated our pioneering joint audit
program, we originally used many audit firms. The thought was the more
competition the better for pricing. While the audit firms were all excellent,
we found that the costs weren’t nearly as favorable to Rx-360, as many of those
firms were regionally focused. Hence, we put out a Request for Proposals (RFPs)
for our entire book of auditing business for a period of three years with the
intent of at least getting consistency in our audit costs. BSI won that bid, and
they have been a great partner.
Finally, in addressing the
importance of international business and working with Rx-360, it is most
noteworthy that our mission is to protect patients by ensuring quality of
medical products and the integrity of the healthcare supply chains in which
those products move. Our supply chains - from raw materials to manufacturing to
patients - are complex and global. There is no single national regulatory
authority that can regulate these supply chains. It is therefore up to us, as
industry partners, to do the right thing by ensuring that our patients, whether
in the USA, Korea, Africa, or anywhere else, are getting the quality medicines
that they and their healthcare providers expect. If we, operating collectively
as “industry”, don’t deliver on the promise of quality medicines and devices to
patients - wherever they may be - then who will, and what are the consequences
to our businesses? All I can say is that if you sell snake oil to a consumer,
that consumer isn’t coming back, but maybe a government will, and neither are
going to be favorable conditions for our businesses in the long run. So, let’s
get rid of that behavior, and let’s get rid of it across the globe by being an
inclusive, quality-driven organization that readily shares best practices with
the rest of industry for patients’ benefit
4. As a CEO of Rx-360, what do you
think is the most important issue in the healthcare industry?
Global delivery of medicines and
devices that are KNOWN to be safe and effective. Healthcare providers expect
that when they prescribe a therapeutic intervention to a patient, then it will
work as expected. They neither know or care where it was manufactured. If that
intervention doesn’t work, they will try another one. The fact that the first intervention
didn’t work because of quality-related problems because it was substandard or
even counterfeited, is not usually on their radar. They expect - and rightly so
- that medical product regulatory authorities are doing their jobs. However, as
noted above, globalization has negatively impacted all patients, including me
and your readers. While the benefits of globalization still exceed the costs,
we can’t tell that to the cancer patient that received counterfeit Avastin in
the USA, or to the large numbers of pregnant women in Ghana who received
ergometrine to induce labor for medically necessary reasons, yet when tested
using statistically significant samples, there was little amount of active
ingredient in either the injectable or tablet dosage forms, if detected at all.
5. You are working with a variety of
leaders in healthcare related industries including pharmaceuticals. What would
you say are the top three priority assets or skill sets needed for companies to
be successful in the global healthcare industry?
Number one, remember that healthcare
providers and patients are your consumers. Number two, please never forget
number one. Number three, please never forget number two. Simple, right?
6. WKMJ has readers from over 10
countries globally. Please share your final words or thoughts with our readers.
I don’t want to cause sensationalist
concerns here. But manufacturers of medicines and devices are in the business
of helping patients. If that is not your business’s primary concern, then exit
this industry. For those that focus on patients, the rewards - financial and
otherwise - will be there. In conducting yourself accordingly, please
understand that your patients no longer exist in your country alone. Your
patients exist everywhere across the globe. There is someone, somewhere, buying
your medicine and sending it somewhere else - often to places that you never
even consider as part of your market. Those patients do not need to be
victimized just because they aren’t. Be diligent in your manufacturing and distribution
practices, and know that if you do, you are really helping someone in dire
need. And if you need support, Rx-360 is here and we can help.
Mark Paxton
Chief Executive Officer, Rx-360
Mark Paxton is the first CEO of RX-360, Prior to
joining RX-360, he served as a Regulatory Counsel in the FDA CDER Office of
Compliance where he was responsible for assisting in the development of supply
chain security policies, both domestically and internationally. Before joining
FDA, Mr. Paxton served as Associate Vice-President, International Regulatory
Affairs at the Pharmaceutical Research and Manufacturers of America (“PhRMA”).
In that capacity, he established a number of on-going dialogs and work programs
with drug regulatory authorities throughout, Japan, China, East Asia, India,
Europe and Latin America. Mr. Paxton is also a regulatory attorney by
education, experience, and training, and prior to joining PhRMA, he was in
private practice in Lexington, Kentucky where he focused his practice on food
and drug law. He received his B.S. (1991) and M.S. (1993) degrees in Economics
from the University of Kentucky, and his J.D. from the University of Dayton
School of Law in 1998.