- Drug company executives are under pressure to bring down the cost of prescription drugs.

They've even been called to testify before Congress.

But it's not the first time.

- In the late 1950s, a similar conversation over drug pricing was soon overtaken by one about safety.

When a tragedy began to unfold.

A pill given to pregnant mothers was leading to devastating birth defects worldwide.

- That pill was thalidomide and it's largely responsible for the drug safety system we currently rely on.

- Pharma executives, all of you that are here today are here because the way you've been doing business is unacceptable.

- [Woman] Drug company executives were recently called to testify about what has lead to America's skyrocketing prescription drug costs.

- Let me just say, I think that you charge more here because you can.

- [Woman] One drug they focused on was Revlimid.

- Today it sells for about $18,000 for a 21 day supply.

- [Woman] Revlimid is a derivative of a drug called thalidomide.

And long before it became a poster child for rising drug costs, thalidomide was a cautionary tale for drug safety.

That story begins in the 1960s with a warning from the president.

- Every doctor, every hospital, every nurse has been notified.

Every woman in this country, I think, must be aware that it's most important that they check their medicine cabinet and that they do not take this drug.

- [Woman] Only two years earlier thalidomide, a sedative billed as the latest pharmaceutical marvel, had been set to arrive on American shores.

- A hypnotic as the doctors call it.

There was the answer to a prayer.

- The hallmark defining quality of thalidomide was its safety.

So safe, that in Germany, there was no prescription needed.

- [Woman] The German company that developed thalidomide, Chemie Grunenthal, claimed that even pregnant women could take it.

- The drug company had handed out samples of this drug all over the place.

Starting with employees of its own company.

On Christmas day in 1956 a baby girl was born in Germany without ears.

And she was the daughter of an employee of the drug company Grunenthal.

- [Woman] No immediate connection was made to thalidomide.

Which soon sold almost as well as aspirin in some European countries.

- We received it in quantities like a thousand pills.

It was tremendous pressure all over the world to get this wonderful new drug on the market.

- They had two million tablets ready to go the moment the FDA approved the drug.

Which was almost a forgone conclusion.

Until one doctor came along and began working at the FDA.

- It just so happened that my first application was for the drug thalidomide.

I got this because I was new and they thought I should have an easy one to start on.

- [Woman] But Dr. Kelsey was uneasy with what she saw as the lack of rigorous scientific studies.

- The best thing that could be said about thalidomide at the time was simply that you could not kill a rat, no matter how much thalidomide the rat ate.

- [Woman] With thalidomide being prescribed for morning sickness in other countries, Kelsey became particularly concerned with what affect it might have on a developing fetus.

In June of 1961 an article appeared promoting its safety during late pregnancy.

- It was allegedly written by a Dr. Ray Nulsen.

But in fact, the article was written by the medical director of the drug company.

- [Woman] About six months later, long ignored evidence became public in Germany, linking thalidomide to a rash of birth defects.

Although hundreds of thousands of pre-market samples had been provided to American doctors, Dr. Kelsey's stubborn delay of the drug's approval for more than a year had prevented a similar scale of tragedy from unfolding in the United States.

- Dr. Kelsey was absolutely a unique hero in American history.

- [Woman] But thalidomide's reach continued to be felt across the rest of the world.

Including in Trinidad and Tobago, where Giselle Cole was born.

- When I came along, I'm a first born.

And they were a young married couple.

I was never unloved, or not wanted, or anything like that.

But I would be foolish to think that it was easy for them.

My disability is, the official term is phocomelia, coming from the Greek meaning shorter arms, or flipper like.

I think people always expect that I would of been angry.

And I'm certainly not angry, and never have been.

- [Woman] Long discussed but seldom implemented, major regulatory reforms were finally forced on the pharmaceutical industry following the thalidomide scandal.

- For some time, President Kennedy has tried to get Congress to approve new control but without much success.

Now, with the thalidomide scare, most of the opposition has melted.

- Largely, the same FDA guidelines that we live under today were created in immediate wake.

- [Woman] These regulations were too late for thalidomide's thousands of surviving victims across the world, who soon became the story.

- [Man] Philip of Brad Born is one example.

Her mother rejected her.

- [Man Narrator] 10 year old Cole Zavies leads a relatively normal life for a boy without arms.

- Another young mother, her husband, her sister, and her doctor are charged with the mercy killing of her deformed infant.

- I'm one of the lucky ones.

In that my parents were adamant that I was their daughter and their daughter first before anything else.

And I was treated as such.

Many were put in homes because they just didn't know what to do.

Some families battled with doctors to have amputation of fingers, and toes, and whatnot.

To accommodate these prosthetics.

Many families were broken, irrevocably.

- [Woman] Instead of quickly settling, the drug companies dug in.

With Grunenthal originally arguing that the children's deformities were caused by everything from nuclear fallout, to botched home abortions.

Anything, but thalidomide.

- It was a very long and difficult process.

- [Man] British thalidomide children, so far, have not received any compensation from the rich company that made the drug, which cripple them so brutally.

- [Woman] Most cases were eventually settled but litigation continues with some survivors saying the original settlements cannot cover the cost of their specialized care.

Grunenthal didn't apologize to its victims until 2012, 50 years after the tragedy unfolded.

- They issued a statement saying that it has taken them the 50 years to come forward to say anything because they were shocked.

They don't have a right to be shocked.

The shock doesn't belong to them.

- [Woman] Despite all that thalidomide's victims endured over the decades, they could long take solace in one simple fact.

- Thalidomide is now banned everywhere.

- They now ban thalidomide.

- [Woman] The drug was banned in 1962.

- [Giselle] And I would of liked to have seen it never used again.

- [Man] This tremendous amount of luck and science, it's almost like an Easter egg hunt.

- [Woman] In 1992, while conducting research into macular degeneration, ophthalmologist Robert D'Amato began his own hunt.

This one to find a pill that might restrict blood vessel growth.

- I started searching for drugs that cause some sort of damage to a fetus, a birth defect.

And at the top of this list was thalidomide.

- [Woman] After much trial and error, Dr. D'Amato finally had breakthrough when he demonstrated that thalidomide could starve blood flow to cells.

A discovery that held the potential for treating cancerous tumors.

- The people that really understood the results were excited because we had a tool that we didn't have before.

But the knee-jerk reaction was, this is a dangerous drug, no one would ever want to use it.

There was thousands of victims that still remain.

There had been a promise that thalidomide would never be developed again.

- We had to make a decision, what position we we were going to take.

Many would have thought, and expected that we would of been screaming, no, no, no, no, no.

- [Woman] But following a surge of reports about promising studies, that's not what happened.

- We are nervous.

We are, of course, frightened and dismayed.

But we realize that this is not a perfect world.

- [Man] Thalidomide is back.

- The Food and Drug Administration says thalidomide will be the most restricted drug ever distributed.

- Female patients taking the drug will even have to submit to pregnancy tests.

- [Woman] Since then, thalidomide has gone on to combat a surprising variety of diseases.

From tuberculosis and Crohn's disease, to multiple sclerosis an leprosy.

And D'Amato's hunch about the drug's affect on cancerous tumors paid off.

In a ground breaking treatment for certain types of the disease.

- Thalidomide and its derivatives have become the primary treatment for multiple myeloma.

- It's a very fine line that I walk, and many of us walk, when we think about thalidomide in today's world.

Clearly you can see what it has done to the thousands of us who are still on this earth.

But if it provides some kind of assistance, help, relief of suffering, then I cannot, in good conscience, be opposed.

- [Woman] Brinner, who saw thalidomide's curative powers firsthand after being prescribed it for a deadly skin disease, says that the drugs circuitous history tells us a great deal about the accidental nature of drug discovery.

- It's kind of surprising, I think, to most people to learn that drugs are, in fact, developed and then become, as they're called, a drug in search of a disease.

- [Woman] But for all its benefits, the scientific rehabilitation of thalidomide has come with a heavy cost.

- [Man] We were told, this could never happen again.

- [Woman] In Brazil, where the drug is used extensively to treat leprosy, researchers have documented that new thalidomide children have been born.

- [Man] Allen, who's eight, has been terribly damaged by thalidomide, which his mother took by accident when she was pregnant.

- 50 years down the road I would like to think there's no such thing as thalidomide.

That we have created something, that we have developed something that would allow us to bury thalidomide.

Literally.

Destroy it, get rid of it.

So that there are no further discussions.

Other than a note in history.