Hurricane Maria causes health scare on mainland

The article all but admits that no one in the DC Swamp monitors critical items in health, energy, security, etc., in which the item is manufacturered or supplied more than 50% from one location in the U.S. or its territories.

No one in the DC Swamp checked the path projected for Hurricane Maria to see if it was likely to hit areas (like Puerto Rico) where a listed critical item is manufactured or a major (>50%) source of supply.

No one in the DC Swamp had an emergency plan, initiated ahead of a likely imminent disruption in a critical item, to contact other minor suppliers or manufacturing sources to see how rapidly they might be able ramp up on a short or long term basis.

No one in the DC Swamp quickly implemented an emergency plan to allow regulatory discretion for additional temporary special importation of suitable supplies of the identified critical item from manufacturers or sources in Europe or elsewhere.

Tell me again why the DC Swamp should not be drained.

No one in the DC Swamp quickly implemented an emergency plan to allow regulatory discretion for additional temporary special importation of suitable supplies of the identified critical item from manufacturers or sources in Europe or elsewhere.

The article says the FDA is allowing this.

This is kind of a big deal.

no one in the DC Swamp monitors critical items in health, energy, security, etc., in which the item is manufacturered or supplied more than 50% from one location in the U.S. or its territories.

Why do they have a monopoly on the product? Or is it another government scam and some congresscritters are getting kickbacks?

Everything dealing with our healthcare must be brought back to the USA to be produced and distributed here! That includes all prescription medications that are being produced in third-world holes where they’re “not” inspected adequately and we don’t even know what’s in the drugs. The fillers are causing many to have horrible side effects which results in more medications being prescribed to combat the side effects or permanent harm or death.

We need to ask the Trump Administration to make this a priority. Bring our prescription drugs back into the USA where they’re inspected!!!

Obama and his Liberal RAT cohorts, who don’t give a damn about We The People, have destroyed our healthcare system. You and I are paying the price in many ways up to and including disabilities and possibly death because of bad, inferior drugs that are not inspected.

Check this out:

https://www.peoplespharmacy.com/2013/12/23/post-14/

Under Comments at the link above: Comment by Terri NC
August 31, 2017 at 3:45 pm

I am a migraine sufferer. Approximately 18 mos ago I was put on beta blocker Metoprolol (25 mg twice a day) as a preventative to reduce headache frequency and severity. I had no problems with the medication, other than slight lethargy and a few pounds gained. About 6 weeks ago, however, my pharmacy advised they had switched to a different manufacturer, and things went quickly downhill.

My bp, which is usually steady and in the good range of 120/67 started going all over the place from lows to highs, with accompanying rapid heart beats of as much as 90 – 118, other than my normal of 62 – 68. I felt lousy, going from being extremely cold, especially in my lower legs and feet, to breaking out in a sweat at the smallest task such as getting dressed.

I had rapid weight gain (10 lbs in two weeks), several anxiety attacks (which I had never suffered), swelling in my ankles, blurred vision, dizziness, a dull headache which lasted for days and fatigue so bad I could hardly get out of bed. My brain felt as if it were in a total fog, and I couldn’t remember something I had done five minutes earlier. At first, I thought the issues were caused by seasonal allergies and a sinus infection, but after the infection cleared, the symptoms grew worse to the point I could hardly get out of bed. Not taking the drug one evening resulted in my feeling much better upon waking, but as I started moving around, my bp hit 146/86 with pulse of 92, and knowing that beta blockers should not be stopped abruptly, I took the dose, which caused things to get even worse and I quickly ended up in my doctors office with a bp of 170/100 and a pulse of 118. After blood work, urinalysis, EKG, my physician and I both believed the culprit to be the new manufacturer.

In the past three years, I have had allergic reactions to three generic drugs, two of which I had taken regularly without previous issue , but each issue coincided with a “new” manufacturer who provided higher profits to the pharmacy or the pharmacy wholesaler. One reaction was anaphylactic, with my throat closing, my tongue swelling and rapid heart beat. As reports of allergies and side effects increasing with generic drugs, and knowing my sensitivity to many unknown inert contents of generic drugs coming from offshore manufacturing facilities, I now carry an Epi Pen with me at doctor’s suggestion.

As a former manufacturer of generic OTC drugs, and pioneer in the generic industry, I feel I am qualified to comment on the problems now created by the off shore manufacturing of these drugs, which have little (if any) FDA oversight, no knowledge of the inert ingredients which are being used nor proper oversight to insure that Good Manufacturing Procedures are being followed. Shocking reports of unacceptable ingredients and manufacturing practices being used in some formulations are escaping the once watchful eye of the FDA regularly.

When I, and my colleagues, first began manufacturing generic drugs to provide alternative low cost pharmaceuticals to public, the FDA guidelines were clear, and the “main ingredient” of the compound was strictly overseen and variances in effectiveness or compound contamination was almost non existent. The drugs mimicked the branded (patented) compound, and the only difference allowed was a small variance in the effectiveness of generic drugs compared to branded products. This was measured by the rate of dissolution of the main drug compound upon ingestion. Generics were highly effective with few problems, and a blessing for consumers who could not afford the high cost of many medications.

As manufacturers moved offshore in search of greater profits (and no doubt, lack of oversight by the FDA) and more and more start up companies entered the market to grab a share of the huge profits being generated by generic manufacturing. The quality of the main compounds began to falter, and the inert ingredients began to include questionable content, which was overlooked or unknown by the governing agencies.

Today’s imported generic pharmaceuticals studies have shown that the difference in bioavailability (effectiveness) can be as much as 40% in imported generic medications, and the inert ingredients unknown and often dangerous. Today with the number of manufacturing facilities in India alone totally between 5,000 and 11,000, it is impossible for a handful of FDA regulators to properly oversee such a large number of manufacturing facilities.

Some reports say as few as 19 FDA inspectors oversee these 5,000 FDA facilities in India. Like many other government agencies, the FDA seems to be employing greater numbers of personnel who are either inept, or indifferent, but even if 100% of the personnel were top notch qualified, it simply boils down to not enough inspectors to properly oversee the number of manufacturing facilities. Side effects from either the inert ingredients, or the huge variance in effectiveness of the compound means continued illness, or side effects, which often mean hospitalizations or visits to ER’s or physicians and a battery of tests to determine the cause of complaint.

As a huge proponent of generics and a pioneer in the industry, I am concerned about the quality and safety of generics. As more and more companies began manufacturing off shore, and more start up companies are created to grab lucrative profits, problems continue to arise. Where once any drugs coming into the US had to meet strict guidelines and testing, including unannounced FDA inspections of manufacturing facilities and the finished product, problems such as these were almost nonexistant. As generic pharmaceuticals began to be more desired by consumers, the number of offshore manufacturing facilities rapidly increased.

In an attempt to make a statement and encourage companies to have GMP (Good Manufacturing Practices) the Justice Department, a few years ago, fined a dozen or so pharmaceutical giants who were manufacturing in India and China under less than desirable conditions, causing them to pay hundreds of millions of dollars in fines for their misdeeds. The companies gladly paid the fine, but continued to manufacture with few, if any, changes, based upon the huge profits available in the generic industry.

Chain pharmacies and distribution companies have enjoyed huge profits by encouraging consumers to buy generics, to use mail order prescription services and via other programs initiated for profit. Recently pharmaceutical giants like CVS have decided to enter into the manufacturing arena, grabbing more of the profits, and will eventually put them into a monopoly situation in an industry which is already enjoying huge profits with less and less benefit to consumers. Several top pharmacy chains were recently hit by a lawsuit for overcharging consumers who bought certain generic drugs with their insurance coverage, while the proceeds (co-pays) were kicked back to third party pharmacy benefits managers!

Consumers would have been better off paying cash, which often resulted in less out of pocket costs to them than the co-pay on purchases through their insurance. In addition to these kinds of tactics, we have no idea of the effectiveness of the main compound, nor do we know what additional ingredients are being used in generic manufacturing, or what kind of sloppy manufacturing practices may be involved. We have no option to sue if things go badly, as offshore generic companies have repeatedly been deemed to not be responsible for side effects in generic drugs since they are “copying the original formulation of the original drug” and the original drug and the generic drug have been approved by the FDA. That does not address, of course, the manufacturing process, which can vary from the original formulation via unacceptable practices of the manufacturer and which may be overlooked or unnoticed by the FDA. Many ingredients have been shown to be unacceptable by regulations, and by consumers who have become extremely aware of what they ingest.

The initial intent of generics was to provide lower costs medicines to the public, thereby reducing health care costs not only for the consumer, but for the many agencies who face astronomical health care costs. For people without insurance coverage, or with coverage which did not cover prescription costs, generics were a blessing. Now, the generic medications are working in reverse, increasing side effects or reducing effectiveness, which often results in hospitalizations, increased doctor visits, and the requirement of more medications. This of course, has the opposite effect of the original intent. In typical style, the government is stepping over dollars to grab for pennies, while concerns continue to fall on deaf ears of those in charge, with cost savings becoming a distant memory. Doctors hands are tied, based upon Medicare/Medicaid and big insurance companies requirements that generic drugs be the first choice and sometimes, only option. In many cases, if the patient or his doctor chooses a branded product, the consumer pays a penalty to his insurance company which can be as much as $100 per month, or the patient must pay out of his own pocket for the branded drug, which costs can be as much as $400 to $1000 for branded product versus a 90% reduction in cost if they accept a generic. It becomes a choice based solely on the dollars, but is this wise?

In my case, another generic beta blocker was prescribed and seems to be working without issue. Had I not the background in generic pharmaceuticals, I most likely would not have been able to pinpoint the basis of my symptoms which could have resulted in a diagnosis calling for yet more drugs to be prescribed, or if left unattended, could have resulted in some major event such as heart attack or stroke.

All drugs are not created equal, sadly, and consumers must arm themselves with as much knowledge as possible, and we must fight back against the tide of low quality and dangerous generics. I still believe in the concept of generic pharmaceuticals, but recognize that the lack of integrity in manufacturing, oversight and regulation leaves much to be desired, and questioned, in today’s generic world.

Anyone have stories to relay regarding this topic??

They don’t have a monopoly - just a majority share. As the items have expirations dates associated with them (due to sterilization requirements) no one holds beyond a certain amount of additional stock to offset when a major factory goes off line as occurred.

To offset it would require incentives similar to farm subsidies (which I would oppose) or government agencies holding a certain amount of stock for items which are considered critical. In the stock scenario - if the items aren’t used by a certain date they are required to be disposed of due to the expiration. (Yes - some durable products can be resterilized, but that would not be the case with IV bags described in the article.).

I’ve worked in the med device world for nearly 18 years. Other sources, already ok’d by the FDA as emergency alternatives, will pick up the slack. The market is tight but the article overhypes the issue and as always the market will correct itself.

The only regulation that might be considered by the government to prevent a similar situation is to state that no more than x% of a given critical product can be produced at any one location. Now... figure out how to calculate that and to define what generally and/or specifically enough what a critical product is considered to be. Someone will still be picking winners and losers in that situation.

Don’t forget Puerto Rico IS the United States. It’s a territory and all PR citizens are US Citizens.

Wonder if all those collection bags that Red Cross
uses for whole blood and apherisis will be affected.

Believe they are all Baxter too.

Hospitals out of financial necessity are becoming masters of the just in time supply chain. In case of crisis with no resupply, many hospitals would be as empty of drugs and material as grocery stores would be empty of food.

I know that PR is a US territory, but I doubt anything coming out of there is quality based on what I’ve heard from friends who have been there!