Discovery responds to FDA review approvable letter for Surfaxin
WARRINGTON, Pa. Discovery Labs submitted its complete response to a Food and Drug Administration approvable letter it received in May for the drug Surfaxin.
Surfaxin (lucinactant) is designed to treat respiratory distress syndrome in premature babies. The FDA’s guidelines state that the agency will notify Discovery of a potential approval date by Oct. 31.
The approvable letter did not require additional clinical trials, but did require Discovery to satisfy International Conference of Harmonization guidelines related to specifications for lipid-related impurities in two of the ingredients in Surfaxin, as well as an additional preclinical studies for quality control.
Discovery said the FDA could approve the drug within six months, depending on how it classifies the company’s complete response.
Steal this column
Why not? I did. I stole every idea from Health and Human Services secretary Mike Leavitt, CMS acting administrator Kerry Weems, Rhode Island Gov. Donald Carcieri and a few others earlier this month in Boston at the National E-prescribing Conference, hosted by CMS and some 34 other co-sponsors, including NACDS and NCPA. The two-day event focused on the potential electronic prescribing has to help fix so much of what is wrong with health care in America today.
I routinely take shots at politicos and policy wonks who I believe just don’t get it as it relates to the issues that matter to community pharmacy. So, it was refreshing to hear some of our country’s leaders talk about what e-prescribing could do to transform health care from the highly fragmented, robust and rapidly growing sector of the nation’s economy, as Leavitt noted during his opening comments, to a system where key stakeholders actually communicate.
Detractors have pointed to the privacy issue. That’s kind of silly, as Leavitt, and Carcieri before him, pointed out—granted, I am paraphrasing a bit here because that’s what it sounded like to me. The privacy issues around e-health are, in a word—one Carcieri actually used—solvable.
How can he be so sure? Every day billions of people use ATM cards in machines all over the world that are not part of the banks that hold their money, with a reasonable expectation that no one else will see their banking records.
While the overarching purpose of the event was no doubt to promote physician adoption of e-prescribing software, sometime during the course of the event it occurred to me that the real opportunity to drive e-prescribing is to get the consumer on board.
The reality, as Paul Cotton, a senior lobbyist for AARP, explained, is that “when consumers start to learn about it, they want it.” According to a recent survey of AARP members, 9-out-of-10 older Americans want e-prescribing to enable their doctors to:
Check their medication history;
Determine insurance coverage; and
Send prescriptions directly to the pharmacy.
But it’s more than just telling consumers the positive story about what e-prescribing means for them; I believe Americans need to understand the negative implications of not moving forward with widespread physician adoption as soon as possible and what it means as an important first step to the creation of a national healthcare information technology infrastructure—and what it means for America to continue to limp along without one.
Because as it stands right now, their personal health records and medical histories are captured in countless manila folders in the filing cabinets of every physician that has ever treated them. And guess what? They can’t talk to each other, and, as a result, each one is an incomplete record. Carcieri believes he has 30 or more manila folders of his own stored in doctors’ offices across Rhode Island.
That means if you got hit by a bus tomorrow, it is likely the ER would know nothing about you by the time you got there. “Meanwhile, FedEx can tell you where a package will be anywhere in the world three hours from now,” Carcieri said.
Tell that story to as many consumers as you can and see what happens with e-prescribing over the next few years. You can steal this column if you need to.
Guest Opinion: Big Pharma needs retail pharmacy to beat odds
You think retail pharmacy’s got it tough? Take a look at what the drug companies are up against:
Expiring drug patents
Increasing pricing pressure
Lower reimbursement rates
Laborious new drug launch processes
Endless reams of bad press
Prescription drug revenue growth is down; script growth is anemic
Few new blockbusters on the horizon
How will drug companies respond? Many have said they will shift into devices, vaccines, generics, OTCs, biotech and emerging markets.
So, what does this mean for retail pharmacy? Doesn’t having a big percentage of its volume coming from prescription products mean that retail pharmacy is vulnerable to a slowdown in Big Pharma prescription sales?
Maybe it’s just the right prescription for fast-forwarding retail pharmacy’s move into consumer-directed health care.
Since drug companies will be launching fewer Lipitors, Levitras and Avandias, they’ll have to find a way to sell more of the safe, effective drugs they already produce.
No one can do this better than retail pharmacy. Retail pharmacy has the ability to reach millions of patients every day and to extend life-enhancing—and life-saving—MTM services to patients with chronic illnesses. No one else has 150,000 highly educated medical professionals trained to deliver pharmaceutical counseling. This, of course, can mean better drug compliance, and better drug compliance means better sales. And, with retail pharmacy and Big Pharma squarely behind e-prescribing, there’s an even greater opportunity to improve compliance and sales.
That’s not all. As drug companies move away from blockbuster drug launches, they will invest more on front-end products, particularly OTC drugs. In this case, who’s going to promote, carry and sell these products?
Make no mistake, retail pharmacy will be the beneficiary of these new efforts among the pharmaceutical companies—which undoubtedly will be supported with millions of promotional dollars. With thousands of stores, millions of shoppers and a small army of pharmacists, techs and nurses, chain pharmacy is perfectly positioned to help sell these new OTCs and reap the rewards of having done so.
In the end, by developing a wider range of efficacious OTCs and new devices, Big Pharma will give retail pharmacy a way to offset the lack of new blockbuster drugs. And, by supporting e-prescribing and developing innovative, practical compliance programs, retail pharmacy and pharmaceutical manufacturers can increase the number of scripts filled.
Patients get healthier, drug companies find new ways to improve their business and retail pharmacy makes both possible—not bad.